URGENT NOTICE: Due to annual leave, we will be unable to deal with any sponsorship communications or applications received between the 20th to 27th May 2022. Due to a high volume of applications currently awaiting review, anything that is received after 13th May 2022 could also incur additional delays and may not be dealt with until W/C 30th May 2022.
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.
The RSO will confirm full sponsorship and insurance cover and work with you to submit to the required regulators and ensure the correct documents are in place.
You should submit the following information to the RSO (firstname.lastname@example.org) to begin the sponsorship process:
- Evidence of peer review (if applicable)
- Draft Protocol
- Draft IRAS form
- Applicable draft Participant documents e.g., Participant Information Sheet, Consent Forms, GP letter
- Details of any statistical engagement
- CV of the Chief Investigator or Student (if applicable)
- Draft Organisation Information Document (OID) and Schedule Of Events Cost Attribution Template (SoECAT)
- Evidence of funding (where applicable)
- Details of any collaborations with external parties, including commercial entities and suppliers
- Any conflicts of interest
The sponsorship review process will commence. This may consist of support and advice in the following:
- Study costing and financial management via the RSO finance teams
- Contractual matters via the RSO teams
- Regulatory submissions via the RSO teams
- Study management and oversight advise via the RSO teams
- Patient and Public engagement via the RES teams
- Medicinal Product support and vendor auditing via the RSO teams
- Confirmation of Insurance
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 Clinical Research Support Officer or your Faculty Research Ethics Officer.
If your study needs NHS approval, please complete the Integrated Research Application System (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 email@example.com. 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.
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: firstname.lastname@example.org
- 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 Ms Claire O'Donnell, Acting Head of Research Quality and Policy, Lancaster University, LA1 4YT Tel: +44 (0)1524 592981, email email@example.com
- 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 - Could the research lead to the development of a new product/process or the generation of intellectual property?
We recommend that you select ‘Yes’ if:
- your research could lead to the development of a new product/process
- you are producing anything other than scholarly works*.
*Definition of Scholarly works: “Scholarly works shall include [but not be limited to] Journal Articles, Conference Papers, Theses and Essays, Textbooks (“Scholarly Works”).”
To note, if you wish to change your answer to this question after your project has been approved you can submit an amendment.
- 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”
Step 6 - HRA additional required forms
The Health Research Authority has recently introduced the UK Local Information Pack, a key component of which is the Organisation Information Document (OID), which replaces the Statement of Activities that were used in England and Wales for non-commercial studies, and the NHS/HSC Site Specific Information (SSI) Form that were used in Northern Ireland and Scotland. Please visit IRAS webpage for more information.
Please carefully read the guidance below on how to complete the OID. Where specific guidance on a question is not given below, please refer to the OID guidance on the IRAS website.
Note: The OID guidance is very specific with respect to version control and file naming. Please read the guidance and ensure that you have used the correct file name and footer formatting.
Question 3: The legal name of the sponsor is Lancaster University.
Question 4: Name of the main contact for the study.
Question 8: please carefully read the OID guidance when completing this question.
Question 10: please note that the OID guidance states that, for many studies, the detailed dates requested may not be applicable (N/A) and this may be stated in answer.
Question 12: Complete this question with advice from the site(s) you are working with regarding anything required to successfully set up and deliver the study.
Question 13: Please use the following text in answering this question “Lancaster University provides online research integrity training, available to all staff and research students, as well as mandatory information security training. Researchers can also access a range of relevant training programmes through the University’s Organisation and Educational Development division.”
Question 14: Please use the following text in answering this question:
If your research is NOT a clinical trial: “The Sponsor expects that researchers complete any training relevant to the proposed area of research (e.g. any relevant clinical training, or training relating to the use of specific equipment/devices/questionnaires) before research commences.”
If your research is a clinical trial: "Researchers undertaking a clinical trial, must renew their Good Clinical Practice (GCP) training every two years. The Sponsor also expects that researchers complete any training relevant to the proposed area of research (e.g. any relevant clinical training, or training relating to the use of specific equipment/devices/questionnaires) before research commences."
Please note if you are undertaking a clinical trial you will be asked to provide evidence of your most recent GCP training completion as part of university governance checks before approval.
Appendix 1 General Provisions: Please select Organisation Information Document.
Please delete clause 2.15 from the document.
Appendix 2 Finance provisions: please complete as appropriate to your study/project
Appendix 3 Material Transfer Provisions: please complete as appropriate to your study/project
Appendix 4 Data Processing Agreement: Please note in the OID guidance documents the comment on Clause 5.(b): “If the participating NHS / HSC organisation will not be receiving referrals from Participant Identification Centres (PICs) for the study, the yellow highlighted text at 5, b should be deleted prior to sharing with the participating NHS / HSC organisation (this may be removed before submitting the outline Organisation Information Document in IRAS, where no organisations to come under the document will use PICs). Similarly, where the participating NHS / HSC organisation will be sub-contracting data processing to PICs but each such PIC sub-contract must be agreed individually in advance by the Sponsor, the yellow highlighted text should be removed. The yellow highlighted text should be retained, and the highlight removed, only where the Sponsor is authorising the participating NHS / HSC organisation to sub-contract with PICs without the Sponsor approving each individual sub-contract in advance (albeit that the participating NHS / HSC organisation will notify the sponsor of new PICs in advance of activating their PIC activity).”
Appendix 5 Data Sharing Agreement: Please complete as appropriate to your study/project
Appendix 6 Intellectual Property Rights: Please complete as appropriate to your study/project, noting our definition of IP in Step 4 'Lancaster IRAS guidance'.
You will also need to complete either a Schedule of Events OR a Schedule of Events Cost Attribution Template (SoECAT). Please refer to the guidance on the IRAS website and complete one of these as appropriate to your project.
Step 7 - Additional information required
Before you submit your IRAS application to firstname.lastname@example.org read the guidance below:
A health and safety risk assessment must be carried out for your study if necessary before you submit your IRAS application to email@example.com (we understand that most projects require a risk assessment). Please ensure a risk assessment has been considered before you submit your IRAS application and in your email to firstname.lastname@example.org state whether a university health and safety risk assessment has been carried out; if it has not please confirm the reason.
To note, carrying out risk assessments are under the remit of the Safety Office please contact your Area Safety Officer if you have any questions about carrying out a risk assessment for your study or need assistance with completion of a risk assessment if you are a member of staff. If you are a student you should contact your supervisor about this.
Additionally you must check whether any third party agreements are needed for your project. If so have these been completed? (If you are a student you should ask your supervisor about this). When you submit your IRAS application to email@example.com, in your email please state whether any third party agreements are needed for your project and if so whether they have been completed.
Step 8 - 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. Please read the guidance below carefully as there are 2 different routes for different types of IRAS applications:
1. If your IRAS application needs NHS REC review email it directly to firstname.lastname@example.org in a single pdf including the IRAS application form, and all supporting documents; such as participant information sheet, consent form, interview questions, questionnaire(s), etc.
Please ensure that the LU logo is present on all participant materials, and include version numbers (starting at 0.1) and the date in full (dd/mm/yyyy) on these materials. Send this single PDF together with separate documents for your OID and Schedule of Events/SoECAT via e-mail to email@example.com. The Clinical Research Support Officer will process your application, they will arrange to send it to the Chair of your Faculty Research Ethics Committee for sponsorship approval.
To note IRAS applications that need NHS REC review must not be submitted in REAMS*.
2. IRAS applications that do not need NHS REC review but do need HRA approval will need ‘sponsorship approval’ and review by your Faculty Research Ethics Committee (FREC) to meet the University’s requirements. For example, this usually applies to research that will involve recruiting NHS staff only to participate (and no patients will be recruited).
In this case follow the guidance below:
a) Submit your IRAS application form to your FREC for review and approval before research begins. From 1st November 2021 you should use REAMS, the University’s online system, to submit your IRAS application to your FREC for ethical review. You will be prompted to upload copies of your IRAS application form, participant information sheets, consent forms, interview questions, questionnaires, etc in REAMS. The system is accessible from this link along with further information and User guides.
b) If/when your FREC grants ethical approval you must email a copy of your IRAS application form with all supporting documents (participant information sheet, etc) to firstname.lastname@example.org to apply for ‘sponsorship’.
To note, 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.
*REAMS is the Research Ethics Approval Management System, the University’s online system for managing applications that require internal REC review by a University Faculty Research Ethics Committee.
Step 9 - Lancaster approval process
All requests for sponsorship and ethical review should be emailed to email@example.com 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:
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 firstname.lastname@example.org with details before proceeding.
Step 10 - 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. The NHS will then conduct capability and capacity at the research site. The Sponsor will also need to give the ‘green light’, in order for the study to be able to start be begin recruitment, this will be a short number of questions that the Sponsor will ask the applicant.
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 email@example.com with details before proceeding.
Step 11 - 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 firstname.lastname@example.org.
The HRA have two categories for amendments – substantial, and non-substantial. Examples of each are listed on the HRA webpages.
- 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 email@example.com. 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.
- 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 firstname.lastname@example.org. 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.