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 would like Lancaster University to act as your sponsor, please discuss this with the Clinical Research Governance Officer at the earliest possible opportunity, so that we are aware of any potential or upcoming applications. We advise all researchers to refer to our Clinical Research and Trials webpages and ensure you are familiar with our SOPs, in particular the Sponsorship Forms and Guidance tab. When you have completed all fields on your IRAS application, finalised your supporting documents, and are ready to make a formal application for sponsorship, please follow the guidance below. Not following the guidance below may mean your application is delayed beyond the usual wait times.
It is a requirement that all researchers must complete the NIHR Good Clinical Practice (GCP) training online before applying for sponsorship. You can find out more about GCP training and how to sign up to the e-learning course on the NIHR webpage.
Please be aware that Lancaster University is unable to sponsor Clinical Trials of Medicinal Products and some Medical Device studies. Please contact email email@example.com if you are planning to develop either of the above types of trials, to discuss your project.
Upon application, RSO will undertake a review of your application, 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 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 RSO finance teams
- Contractual matters via RSO teams
- Regulatory submissions via RSO teams
- Study management and oversight advice via RSO teams
- Patient and Public engagement via RES teams
- Vendor auditing via 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. As part of this role, we may delegate some responsibilities to other parties, such as the Cheif Investigator or 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 if you will require a Research Ethics Service (NHSREC) review and/or HRA regulatory review.
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 or post graduate researcher, please also 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'.
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. Lancaster has paused sponsorship of interventional clinical trials and as such, if you feel your project may fall under this, please contact email@example.com to discuss this and for assistance in finding an appropriate sponsor.
- 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 for an experienced HCP undertaking a doctoral-level study who is 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 Helen Brace, Head of Research Quality and Policy, Lancaster University, LA1 4YT, email firstname.lastname@example.org
- 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 transferred 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. Should you be making use of the NHS Indemnity Schemes, please make this selection and enter 'NHS Indemnity Scheme will apply'
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 (See step 11).
- Section D2 - Please do not complete the ‘declaration by the sponsor's representative’ section (this must be completed by the University after sponsorship has been confirmed in writing).
Step 5 - Participant information sheet
Both the University and 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, and who the sponsor of the project is. As of the 1st December 2023, the HRA will make their PIS standards mandatory and all PIS documents submitted to the HRA or NHSREC should follow the standards set out on their webpage. We recommend using the university templates, which can be found on your faculty Research Ethics webpage, also ensuring the information you outline meets the HRA PIS standards. Please ensure that all of the above detail is included, as well as the below statement as it appears:
“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”
You should only use one transparancy and GDPR wording version on your PIS. We ask that you remove the HRA transparency wording in favour of the above information and do not duplicate with both paragraphs.
Step 6 - HRA additional required forms
The Health Research Authority has recently introduced the UK Local Information Pack (LIP), which is a suite of documents you can provide your NHS sites with in order for them to begin the process of setting your project up at site. A key component of the LIP 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:
“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.”
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 email@example.com 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 firstname.lastname@example.org (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 email@example.com 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 firstname.lastname@example.org, 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
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, as well as HRA review, email it directly to email@example.com including the IRAS application form (PDF), and all supporting documents; such as participant information sheet, consent form, interview questions, questionnaire(s), etc. individually.
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 firstname.lastname@example.org. The Clinical Research Support Officer will process your application, they will arrange to send it to the Chair of the Health and Social Care Research Sponsorship 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) For ethical review, submit your IRAS application form to your FREC via REAMS, the University’s online system. 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 email@example.com 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.
If in doubt about the process, please contact the Clinical Research Governance Officer for sponsorship advice, or your Faculty Research Ethics Officer for Faculty REC advice, before submitting your IRAS application.
*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 should be emailed to firstname.lastname@example.org as per step 7 above.
If your application needs to be reviewed by NHS REC, it will first be reviewed by the Clinical Research Governance Officers, who in conjunction with the sponsor representitive and Health and Social Care Research Sponsorship Committee, will then device whether the university can act as sponsor for your research. At this stage you may be asked to make some amendments to your application before sponsorship can be confirmed, once this has been completed, it can be signed off electronically in the IRAS system.
If your application does not require review by a NHS REC (e.g.projects which involve NHS staff only), but does require HRA review, it will need to be approved by the FREC via REAMs, and then considered for sponsorship. 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 email@example.com with details before proceeding.
Step 10 - Following HRA Approval
Once your project is approved by the HRA and/or NHS REC, you will be notified by email. You will then need to conduct site set up, and the NHS will conduct capability and capacity (C&C) checks at the research site. We would advise that you contact the NHS R&D as soon as you are authorised by the HRA to start to ascertain the site requirements and ensure C&C will run smoothly. This will include negotiating site start dates and performance targets, and finalising the OID for signatures by both the site and the sponsor. Once C&C has been granted, and the completed OID has been returned to the sponsor, the Sponsor may also need to give the ‘green light’. This will be a short number of questions that the Sponsor will ask the applicant to confirm, before granting the 'green light' approval to start data collection.
Please remember that you must keep the NHS up to date with your progress, as well as the NIHR if your study is on the NIHR CRN Portfolio. You must also provide the NHS REC with annual reports, and end of study reports. This is a condition laid down by the NHS and it is also a condition of university sponsorship.
Remember, any changes made to your application form in the IRAS system after it has been signed electronically and approved, 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 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 email@example.com.
The HRA have two categories for amendments – substantial, and non-substantial (Examples of each are listed on the HRA webpages). The HRA now use the same application form for both substantial and non-substantial amendments. In most cases, submission is via a different area of IRAS to your initial application. We recommend you refer to the IRAS guidance pages before submitting an amendment request to the sponsor.
For all amendments:
- You must complete the most up-to-date version of the Amendment Tool and send this, along with any other modified documents, such as protocol, participant information sheet and consent form, to firstname.lastname@example.org. Please highlight changes on the documents so that they can be clearly seen. It is helpful to include a summary of the changes you are making in the body of your email.
- The CRGO, and Health and Social Care Research Sponsorship Committee chair or delegate will consider the amendment for sponsorship.
- When the amendment is approved, the sponsor representative will sign and then lock the amendment into a PDF, after which point no changes should be made. If you do change your tool after this point, you will need to resubmit it to the email@example.com email for review. Once the amendment is approved, you will receive an e-mail from us confirming that it is ready to be submitted to the HRA.
For submission, there are two different routes depending on how you submitted your initial IRAS application:
- If you submitted using the standard IRAS platform you will need to submit your locked amendment tool via IRAS Identity Gateway. All up-to-date amendment guidance can be found on the amendments webpage. should your amendment be categorised as substantial, you will also need to notify your chosen ethics committee and ensure they receive a copy of your amendment tool.
- If your project was submitted using the new combined review service, you will need to submit your locked amendment tool and complete an online application via your original application page in IRAS. All up-to-date combined review submission guidelines can be found on the combined review HRA webpage
Attending NHS REC review meetings: Guidance for researchers
This guidance is for staff and Post Graduate students who will be attending an NHS Research Ethics Committee (REC) meeting because their IRAS application requires an NHS REC review.
1. Applicants: should attend NHS REC review meetings when invited to do so by the REC.All NHS REC meetings are now conducted via Zoom, so are accessible from any location. It is worth noting that members usually require clarification of some issues even in well- written applications. Attending an interview will enable you to answer REC members’ questions or concerns about your research at the meeting, clearly and clarify any misunderstandings. This can save a lot of time later in that it may avoid the to-ing and fro-ing of numerous emails after your application has been reviewed in order to supply the committee with the information that it needs to make a decision on your application. If the REC requests revisions to your application, you will have a greater understanding of what is required in order to gain ethical approval for your research.
2. Supervisors: If you supervise a student who has been invited to attend an NHS REC meeting to discuss their IRAS application we strongly recommend that you attend with them, as will the REC. If you cannot attend we recommend that you nominate a substitute, preferably a colleague who is familiar with the project or at least who has sufficient expertise in the subject. The reasons for this are that:
- This is important because it can be very daunting for a student to attend a REC meeting and your presence will help them to feel supported. They may need your assistance to answer members’ questions during the meeting if they struggle at any point.
- Your presence demonstrates to the REC that their supervisor and institution support the student. It gives the REC a very bad impression if students attend a REC meeting without the presence of their supervisor.
3. Before you attend a REC meeting re-read all the documents which you submitted for review; especially the IRAS form and protocol and be prepared to answer questions about the information on any of your documents. In particular, recruitment strategies and methodologies often raise questions or require clarification; especially if a project has several cohorts and/or mixed methodologies, which are very detailed.
4. Arrive for your appointment on time. This sounds obvious but worth noting, as RECs usually have a full agenda at their meetings and it will be helpful to arrive on time to avoid delays.
5. Ask questions! You will be able to ask the committee members questions when you attend the meeting. RECs comprise of many experienced members from a range of research backgrounds and often appreciate applicants asking their advice on a particular aspect of their research.
6. Relax! Remember that REC members want to ‘enable’ research. Many members work in hospitals, the health care sector or universities; they understand the research environment and its challenges and want to help you to do research which follows best practice.
7. Changes required after the NHS REC or HRA review, usually do not need to be made on IRAS itself, unless otherwise stated. Some documents may be requested as uploads on IRAS, but the queries will usually be responded to via email.