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.

If you wish to name Lancaster as your sponsor on your NHS 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.

*In this context, the sponsor is the individual, company, institution or organisation which takes on ultimate responsibility for the management of the research.

  • Step 1 - Do I need approval?

    The Health Research Authority (HRA) has some useful guidance available on their website. This includes a decision tool to help you to decide whether your work will be defined as research, and then what (if any) level of approval will be needed from the HRA.

    Note, if the tools indicate that your project is not defined as ‘research’ for NHS purposes and/or if they indicate it does not need NHS REC review it is likely that your project will need to be submitted to one of the University’s Faculty Research Ethics Committees for review. If in doubt, please contact the ethics team.

    If your study needs NHS approval, please complete the IRAS application form following guidance outlined below. If you are a student, please seek additional advice from your supervisor.

  • Step 2 - NHS approval form (IRAS)

    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.

    Please note, no questions should be left blank on your IRAS form. Instead please indicate the question is not applicable by adding 'n/a'. Leaving questions blank will invalidate the sponsor signature and could cause delays for your project.

  • Step 3 - HRA guidance and training

    Guidance and training for completing your IRAS form is available in detail from the HRA. Their webpages have comprehensive information about gaining approval.

    We advise you book onto the webinar'Applying for HRA Approval – getting it right first time'. Slides for previous sessions are available here.

    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 HRA queries.

    As the IRAS form is not part of university processes we are only able to offer limited guidance. Please refer to the below Lancaster guidance which should help your application progress smoothly. If you are a student, remember to seek additional advice from your supervisor.

  • Step 4 - Lancaster IRAS guidance

    These notes should help you complete 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 clinical.research@lancaster.ac.uk
    • Student applicants - Please answer 'yes' to question 9, 'Is the study or any part of it being undertaken as an educational project?'
    • 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, Deputy Head of Research Services, Lancaster University, Tel: +44 (0)1524 592981, email sponsorship@lancaster.ac.uk
    • Section A22 - It is appropriate to mention the process for participants withdrawing from the research in this section.
    • Section A26 - Include details here of the Lone Worker Policy or Guidance you are following (from which agency or source), outlining the main elements of it that apply to you. You may wish to use the university's Lone Worker Guidance (field work) as the basis for this section.
    • Section A37 - State that data on portable devices will be encrypted; if it cannot be encrypted, confirm that any identifiable data (including recordings of the participants' voices) will be deleted from the recorder as quickly as possible (e.g. when it has been tranferred to a secure medium, such as a password protected PC) and in the meantime the recorder will be stored securely.
    • 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 5 - Participant information sheet

    The HRA require specific wording to be given on your Participant Information Sheet, as well as project specific information on who will have access to personal data, where this data is held and how long for. Please include detailed information about this, as well as the text below:

    “Lancaster University will be the data controller for any personal information collected as part of this study. Under the GDPR you have certain rights when personal data is collected about you. You have the right to access any personal data held about you, to object to the processing of your personal information, to rectify personal data if it is inaccurate, the right to have data about you erased and, depending on the circumstances, the right to data portability. Please be aware that many of these rights are not absolute and only apply in certain circumstances. If you would like to know more about your rights in relation to your personal data, please speak to the researcher on your particular study.

    For further information about how Lancaster University processes personal data for research purposes and your data rights please visit our webpage: www.lancaster.ac.uk/research/data-protection”

    Guidance from the HRA is available on their webpages.

  • Step 6 - HRA additional required forms

    You are normally required to complete two additional documents as part of the review process. These are the Statement of Activities (SoA) and Schedule of Events (SoE). Guidance and templates are provided on the 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.

    SoA, Schedule 2 - Material Transfer Provisions
    You need to 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;
    • Or, 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.

    SoA, Schedule 3 - Confidentiality, Data Protection and Freedom of Information
    You need to consider whether your study involves the processing of personal data by the participating organisation(s) on behalf of the sponsor.

    • If your study does not involve processing of personal data by the participating organisation on behalf of the sponsor, please tick the first box;
    • Or, if your study does involve processing of personal data by the participating organisation on behalf of the sponsor, and the sponsor will be providing separately a GDPR compliant Data Processing Agreement, please tick the second box and contact the Contracts Team with full details of the project, so that they can put a suitable Data Processing Agreement in place for the project.
    • Or, if your study does involve processing of personal data by the participating organisation on behalf of the sponsor and the provisions of existing Schedule 3 (Data Processing) will apply, please tick the third box.

    SoA, Schedule 4 - Data Sharing
    You need to consider whether your study involves the transfer of personal data AND/OR confidential information from/to the participating organisation(s).

    • If you are not transferring anypersonal data or confidential information with the participating organisation(s) then please tick the first box;
    • Or, if you are transferring personal data or confidential information with the participating organisation(s) please tick the second box and append this document to your application (Please ensure that you have read the additional document and comply with the terms in the course of your study); 
    • Or, if you are transferring personal data or confidential information with the participating organisation(s) and the provisions of existing Schedule 4 (Data Sharing) will apply, please tick the third box.
  • Step 7 - Requesting Lancaster approval

    Once you have completed your IRAS form you need approval from a faculty ethics committee Chair before the sponsorship signature will be added. Create a single pdf containing all documents in the order that you will use them this should include but is not limited to:

    • IRAS form
    • Participant information sheet
    • Consent form
    • Interview schedule
    • Questionnaire

    Please ensure that the LU logo is present on all participant materials, and please include version numbers (starting at 0.1) and the date in full (dd/mm/yyyy) on these materials.

    Send this single PDF together with seperate documents for your completed Statement of Activities and Schedule of events (if appropriate) via email to sponsorship@lancaster.ac.uk.

     

    Remember, no questions should be left blank on the IRAS form. Instead please indicate the question is not applicable by adding 'n/a'. Leaving questions blank will invalidate the sponsor signature and could cause delays for your project.

  • Step 8 - Lancaster approval process

    All requests for sponsorship and ethical review should be emailed to sponsorship@lancaster.ac.uk as per step 7 above.

    If your application needs to be reviewed by NHS REC (e.g. projects involving patients) it will be considered first by the Chair of the Faculty Research Ethics Committee (FREC), 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 of this decision. 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.

    If your application does not require review by a NHS REC (e.g. projects which involve NHS staff only) it will need to 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

    Please note, any changes made to your application form in the IRAS system after it has been signed electronically will invalidate the sponsorship approval. If further changes are needed to your IRAS form, please contact sponsorship@lancaster.ac.uk with details before proceeding.

  • Step 9 - Following HRA Approval

    Once your project is approved by the HRA 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.

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

    Remember, any changes made to your application form in the IRAS system after it has been signed electronically will invalidate the sponsorship approval. If further changes are needed to your IRAS form, please contact sponsorship@lancaster.ac.uk with details before proceeding.

  • Step 10 - Amendments

    Under no circumstances must any amendment be submitted to the HRA without sponsor approval – the only authorised sponsor signatory for Lancaster University is obtained via sponsorship@lancaster.ac.uk.

    The HRA have two categories for amendments – substantial, and non-substantial. Examples of each are listed on the HRA webpages.


    Substantial amendments:

    • Complete the ‘Notice of Substantial Amendment’ form in IRAS, and send this (along with any other modified documents, such as participant information sheet and consent form) to sponsorship@lancaster.ac.uk. Please highlight changes on the documents so that the changes can be clearly seen. It is helpful to include in your e-mail a brief summary of the changes you are making.
    • The Faculty REC Chair will then consider the amendment for sponsorship.
    • When the amendment form is ready to be signed off, you will be notified by e-mail. You should request the sponsor signature in IRAS, using the same sponsor details as given in the guidance notes above.

     

    Non-substantial amendments:

    • You Complete the template document on the HRA webpage (approximately half way down the page), and send this (along with any other modified documents, such as participant information sheet and consent form) to sponsorship@lancaster.ac.uk. Please highlight changes on the documents so that the changes can be clearly seen. It is helpful to include in your e-mail a brief summary of the changes you are making.
    • The Faculty REC Chair will then consider the amendment for sponsorship.
    • When the amendment is approved, you will receive an e-mail from sponsorship@lancaster.ac.uk confirming that this is ready to be submitted to the HRA at hra.amendments@nhs.net. Please note that the university does not sign the notification of non-substantial amendment form.