i4i NIHR & OLS Real World Evidence Guidance for Applicants

Please be aware the OLS RWE call closed on the 27/03/2024. Please contact the OLS RWE team i4i-rwe@nihr.ac.uk if you have any further questions.

Section 1: Application Summary Information

Early Value Assessment (EVA) title and product(s)

Please state the EVA title and product(s) to be included in this project, noting only products recommended for early use in the NHS are eligible. For further information, see the NICE EVA website and the list of potentially eligible technologies.

Host Organisation

Provide details of the organisation that will be the contractor if the project is funded. To note, for this Programme, the Host Organisation should be the analytical partner who will lead and coordinate the generation of evidence required.

If your organisation does not appear on the list or you have any queries, please contact i4i RWE before submitting your application.

Project Title

The title should state clearly and concisely the proposed project. Any abbreviations should be spelled out in full.

Proposed Start Date

Note this should be from the first of the month regardless of whether this is a working day or not. NIHR and OLS are committed to the rapid initiation of research following the decision to fund to benefit patients as soon as possible. The aim is for all projects to start 1 October 2024.

Project Duration (months)

Maximum duration eligible is 36 months. Ensure the timelines are ambitious but you include sufficient time to complete all aspects of the project, including writing generalisable guidance and the final report.

End Date

This field will automatically populate once you have entered the start date and research duration information.

Total Project Costs

This will be automatically pulled through from the budget section.

Section 2: CV - Lead and Co-applicants

Some of the responses required in this section will have been pre-populated based on your CV details and any remaining fields must be completed.

The Lead Applicant should be the analytical partner who will lead and coordinate the generation of evidence required. They must be a UK legal entity.

The aim of this award is to support consortia involving an analytical partner (Lead Applicant), technology partner(s) providing the EVA product(s), and adopting sites/services. Technology partner(s) and adopting sites/services should be added here as co-applicants.

Public co-applicants

We encourage the inclusion of public co-applicants, where appropriate. Please include a clear description of their role and the reasons why a public co-applicant is joining the team. They are not obliged to complete a standard CV but are required to provide a summary of any knowledge, skills, and experience relevant to their role in the application in a separate text box. This appears when ‘yes’ is selected to indicate if co-applicants are a member of the public.

We recognise and value the varied perspectives that patients or service users and carers bring to a project as applicants. In this section, please provide a summary of any relevant knowledge, skills and experience that you will draw upon to contribute to this project.

This could include information about:

• Previous or present work (paid or unpaid) with any relevant organisations
• Links with any relevant groups, committees, networks, or organisations
• Experience of particular health conditions, treatments, use of services, being a carer - or as a member of a particular community
• Knowledge and experience of research including previous research undertaken
• Knowledge and experience of patient and public involvement including previous involvement activities
• Skills from any other roles that are transferable
• Relevant qualifications, training and learning.

The bullet point list above is not exhaustive. Please include anything else that is relevant to the application.

For further information please access the Public Co-Applicants in Research guidance.

If the team involves more than 15 co-applicants, list the additional members in the 'Detailed Project Plan' section.

Section 3: Background - Lead and Co-applicants

Publication record

Provide details of a MAXIMUM of 6 of your most recent/relevant publications (in the last 10 years) relevant to this application (using Vancouver or Harvard citation format). Please use DOI reference numbers if needed.

Research Grants Held

Please select research grants held (as a named applicant) currently or in the last 5 years – as well as any additional previous grants, relevant to this application, stating who the grant is with and the amount of each grant. If no grants are held please enter N/A (as this is a mandatory field).

Has this application been previously submitted to this or any other funding body?

To be completed by the Lead Applicant only.

Select ‘Yes’ or ‘No’ from the drop down box to indicate whether this or a similar application has previously been submitted to this or any other funding body.

Applications Submitted to other NIHR programmes

Where this application or a similar one has been submitted to another NIHR programme or elsewhere please complete the necessary information.

We are keen to know if the application has been submitted elsewhere and you must be as open about this as possible. Failure to disclose accurately or fully will be considered by the programme as misconduct and treated accordingly. You should include in this section information on whether this or a similar application has been submitted to any NIHR programme previously, or to any other funder. You should name, and provide the dates and outcomes of these. Please also indicate whether you hold or have ever held an NIHR programme contract which has been terminated prior to completion, or extended in time or in terms of funding.

Section 4: The Project Team

Specify your (Lead Applicant) role in this research

Explain in addition to your role as Lead Applicant, the role that you will be undertaking in the project, e.g. co-ordination and project management, analysis, methodological input etc. noting that for this funding, the Lead Applicant is required to be the ‘analytical partner’.

%FTE Commitment

This refers to the percentage of the time that you will commit to this project. If you are funded as part of other NIHR projects that will be running concurrently, your time must not exceed 100% overall.

Joint Lead Applicant

Where appropriate and justified it is acceptable for the application to be led by Joint Lead Applicants. Where this applies, please complete your name, contact details, and other requested information.

Justification for Joint Lead Applicant

Justification should be given to demonstrate why more than one person would be required to lead this project and how this brings added value to the application.

Relevant expertise and experience of Joint Lead Applicant

Please summarise the proposed Joint Lead Applicant’s relevant expertise and track record in real-world evidence generation and analysis, in terms of skills and experience, previous publications, grant funding, and impact on health service or social care provision.

Specify role in project

Please provide a brief overview of your (Joint Lead Applicant) role in the proposed project. You have the opportunity to elaborate upon this further in the ‘Detailed Project Plan’ section.

%FTE Commitment (Joint Lead Applicant)

This refers to the percentage of your time that you will commit to this project. If you are funded as part of other NIHR projects that will be running concurrently, your time must not exceed 100% overall.

NOTE: For application/contracting purposes, the Joint Lead Applicant will be counted as a co-applicant.

Co-Applicants

Add details of all co-applicants and their specific role in the programme. Do not include collaborators, who should be mentioned (if necessary) in the ‘Detailed Project Plan’ section of the form.

The aim of this award is to support consortia involving

• an analytical partner (Lead Applicant),
• technology partner(s) providing the EVA product(s), and
• adopting sites/services.

Technology partner(s) and adopting sites/services should be added here as co-applicants.

Co-applicants are those individuals with responsibility for the day-to-day management and delivery of the project. Co-applicants, including public co-applicants, are considered part of the project team and are expected to share responsibility for its successful delivery. Co-applicants from collaborating organisations should be included. In contrast, collaborators are individuals (e.g. consultants) or organisations (e.g. sub-contractors) providing specific expertise on particular aspects of the project but who do not share in the responsibility for the delivery of the project. They should be included in the project plan.

Allow sufficient time for your co-applicants to complete their sections of the online form before the application deadline. This includes registration and validation of co-applicant accounts for the RMS portal.

A maximum of 15 co-applicants is permitted (which includes the Joint Lead Applicant if listed).

Section 5: Scientific Abstract

Max 500 words

The scientific abstract should be a clear and concise scientific summary of the Detailed Project Plan/Methods.

The following is a list of potential elements/headings that might be included depending on the design of the proposed study. It will be for applicants to decide the appropriate elements to be included in the scientific abstract and could include elements outside this list. Applicants may find the guidance on the EQUATOR Network website useful.

• Research question
• Background
• Aims and objectives
• Methods
• Timelines for delivery
• Anticipated impact and dissemination

Section 6: Plain English Summary

Max 450 words

A plain English summary is a clear explanation of your research.

Many reviewers use this summary to inform their review of your funding application. They include clinicians, other practitioners, and researchers who do not have specialist knowledge of your field as well as members of the public. If your application for funding is successful, the summary will be used on the National Institute for Health and Care Research (NIHR) and other websites.

A good quality plain English summary providing an easy-to-read overview of your whole study will help:

1. those carrying out the review (reviewers and committee members) to have a better understanding of your project
2. inform others about your project, such as members of the public, health and social care professionals, policymakers and the media
3. the funders to publicise the work that they fund.

If it is felt that your plain English summary is not clear and of good quality then you may be required to amend it prior to final funding approval.

It is helpful to involve patients/carers/service users/practitioners and members of the public in developing a plain English summary.

Content

When writing your summary consider including the following information where appropriate:

1. aim(s) of the project
2. background to the project
3. design and methods used
4. patient and public involvement
5. dissemination

The plain English summary is not the same as a scientific abstract - please do not cut and paste this or other sections of your application form to create the plain English summary.

Further guidance on writing in plain English is available online at NIHR Plain English summaries.

For further support and advice on writing a plain English summary, please contact your local Research Design Service (where applicable).

Section 7: Detailed Project Plan

Max 5,000 words

Using all of the headings (in the order presented) and guidance below, clearly explain your proposed research. Schematics, tables, illustrations, graphs, and other types of graphics can be embedded to clarify the research plan but they should not clutter the central narrative. Images do not count towards the overall word count but inclusion of them to overcome word limits is not permitted. Images may only be included within the 'Project Plan.' Images included in other sections will be removed from the application and will not be seen by reviewers.

As this is the main part of your application which will be considered by the reviewing Committee you should ensure that the information is accurate, succinct, clearly laid out and provides adequate detail. Applicants should therefore aim to reserve a significant proportion of the word limit for the project plan to ensure methodological approaches are fully specified. This section should not exceed 5,000 words.

1. Background

Briefly describe the background of the proposed project. Provide a clear explanation of the health or social care problem to be addressed, the impact on patients/service users, carers or the public as well as health and care services, and how this project would fill a demonstrable evidence gap. Emphasise the importance of the proposed project and its relevance to the priorities and needs of the NHS, public health or social care (including a statement of the significance of the research area, e.g. burden of disease). Explain how the proposed project will deliver on the aims of the Life Science Vision.

2. Description of the product(s) and the evidence accumulated to date

For the product(s) that you will be testing, please include the following:

• A brief description of the product(s) and the unmet need they address
  • The technology type (e.g. medical device, in vitro diagnostic, digital health technology, service improvement, behavioural intervention)
  • The development stage:
    • What level of regulatory approval does the innovation have? Please provide details on whether UKCA/CE certifications are required and whether the proposed product(s) is/are UKCA/CE marked and that the UKCA/CE mark is still valid and covers the intended use for the planned study. Digital Technology Assessment Criteria (DTAC) approval is also required for Digital Technologies and must be in place before they are planned to be used in the NHS as part of the proposed project.
    • Is this innovation currently in use in the NHS or elsewhere? (If yes please, specify whether this is in a research setting, piloted rollout, or routine use)
    • Please describe the level of readiness (e.g. commercialisation in the UK and/or abroad, financial support received, further adaptations needed for adoption).
• Where the product(s) fit within the care pathway. A pathway map showing the innovation-disrupted pathway can be included in Section 11: Uploads. Please aim to include all steps in the pathway (including referral, triage, assessment etc). Where possible please include statistics or percentages of patients/referrals going down the different routes within the pathway.
• The evidence generated to date. Please include any patient outcomes, reference any trials to prove safety and efficacy or evaluation studies, and any relevant data.

3. Real-world evidence requirements and strategy

Describe the outstanding evidence requirements for adoption and the overall strategy your organisation will deploy to ensure the generation of the appropriate level of evidence to progress one or multiple products towards full NICE guidance and uptake in the NHS and/or care settings. Include reference to the below areas:

• Noting the EVA recommendations and Evidence Generation Plan (please include a copy in Section 11: Uploads), detail the evidence required for the product(s) to achieve full NICE guidance.
• Describe any additional requirements to encourage increased uptake in the NHS and/or care settings. Consider how the product(s) would impact health/social services and how the system will need to adapt (including people, processes, and culture) in order to deliver system-wide benefits.
• Describe how the work planned will address some, or all, of these identified needs within the duration of this project.
• Briefly highlight the expected outcomes of the project and how they will support uptake into NHS and/or care settings.
• Describe any existing project support (e.g. funding from other sources) available to the project team, which is relevant to this proposal. Clearly delineate the proposed project from other related studies, funded from another source.
• A key component of this award is to derive generalisable knowledge on real world evidence and implementation best practices; please briefly describe how you will ensure to deliver on this aim. This should then be expanded upon in Section 5.2: Work packages.

4. The consortium and wider team

Please describe how the consortium will work together and how you are best placed to address the evidence needs of the product(s)

• Explain why the group is well qualified to carry out this project, describing the track record of the project team in real world evidence generation, including publication outputs, grant income and impact on health research. Describe the site(s)/service readiness, commitment and vision to implementing innovative technologies.
• Explain how the applicants work together (or propose to work together if they have not done so previously), and identify other major collaborations important for the project. State clearly the particular contribution that each of the applicants will make towards the project and provide an explanation of the role of key collaborators and subcontractors involved in the project, as well as any patient and public leads (not previously listed as co-applicants). To note, sub-contractors provide external specialist services which cannot be provided by the organisation leading the project or its co-applicants or collaborators. Services include, for example, consultancy, design services, or the development and provision of specialist equipment. These costs can be requested for organisations providing these services in a territory that is outside the UK, but suitable justification is required.
• Describe how the chosen location(s) and type(s) of setting are suited to address the evidence needs of the product(s)
• Quantify the patient demographics affected by this challenge and how they compare to that of the adopting site(s) involved in this project and how equality, diversity and inclusion of participants are taken into account and evidenced in the application.

Patient and Public Involvement (PPI) Lead

• In addition to the three consortia partners, there should be a named person with appropriate skills and experience who is responsible for leading the PPI element within the project. This role should be an adequately costed and resourced research team member who is able to manage the PPI plans and related activities. More information and examples of the activities a PPI Lead might undertake can be found in the guidance on the NIHR website.

If, for any reason, salary costs of members of the team are not going to be sought via this application, it should be made clear how their contribution will be supported in the ‘Detailed Budget’ section.

5. Project Plan/Methods

5.1 Aims and objectives

Indicate the overarching aims/objectives of the project and the proposed project exit point.
Provide a summary of the project plan, plus any additional points required to support statements made in the previous sections, and include any key references required to justify the points made (e.g. in the use of particular success criteria, outcome measures or research design and methodology).

5.2 Work packages

The project plan should include a detailed description of work packages, including deliverables and milestones (a Gantt chart must be attached in the supporting information). Clearly state how you would define success at each significant milestone in the project. Note that the milestones stated may be used as part of the contract if your application is successful. Identify risks and describe your mitigation plans. Digital Technologies must be Digital Technology Assessment Criteria (DTAC) compliant before the start of NHS implementation work; if this is not the case, please include it as a deliverable in your project plan.

• Generalisable learnings. A key component of this award is to derive generalisable knowledge on real-world evidence and implementation best practices including effectively leveraging existing infrastructure, as such, a distinct work package should be included. Describe how you will capture generalisable learnings to improve the quality of real-world evidence generation and enhance uptake, including forming effective consortia. Explain how you will use these learnings to develop broader category-wide guidance on real-world evidence generation that will support innovators to improve the clarity and quality of real-world evidence and enhance understanding of what commissioners want to see to encourage increased uptake.

When applicable, you may also want to consider:

• NHS/social care implementation plan. The project design should be targeted to the context where it will be delivered, taking into account appropriate patients/service users/carer cohorts, stakeholders, and end users that will be affected, and the clinical pathway that will be disrupted. Include a clear set of outcome measures that will define the success of the project. Provide the details on the methodology chosen for the study undertaken, and ensure to include the appropriate comparator(s). Plans for data and information governance should be in place.
• Health and Financial impact. We expect the projects to be supported by a strong health economic case from the outset, and the results generated to contribute to it and build a more compelling case for NHS and/or social care adoption.
• Stakeholder engagement. The proposal should describe a stakeholder engagement plan, including end users (regulatory bodies, commissioners, etc.), collaborators and possible contributors (e.g. NIHR Infrastructure, HINs (formerly AHSNs), policymakers, etc.), detailing how they will input into strategic decisions.

5.3 Equality, Diversity and Inclusion for study participants

Applicants are reminded that NIHR strategy encourages projects to follow patient needs. Applicants should clearly articulate how their project meets this objective, and how this contributes to the rigour of their project. Projects should involve participants from geographical areas where patient need is greatest, including for example the rural and semi-rural areas where many older people live, and represent areas of diverse socioeconomic and ethnic diversity.
Every person eligible to take part in research should be offered the same opportunity of taking part in that research regardless of:

• Geographical location
• Age
• Disability
• Gender reassignment
• Marriage and civil partnership
• Pregnancy and maternity
• Ethnicity - for example see:
  • The Centre for Ethnic Health Research toolkit for increasing participation of ethnic minority groups in health and care research
  • The INCLUDE Ethnicity Framework, which aims to improve trial delivery for under-served groups
• Religion or belief
• Sex
• Sexual orientation
• Socioeconomic status
• Access to health or social care

All NIHR applications are expected to include information about how this data will be collected.

In addition, applicants should demonstrate how these factors have been considered and addressed in their proposal, including steps taken to ensure the participants are representative of the population the study is targeted at. Applicants need to explain who they are planning to recruit to ensure inclusivity of study participants and justify and explain any exclusions, for example by completing an Equality Impact Assessment. Costs associated with inclusivity, which may include, but are not limited to justified translation of research participant material into other relevant languages, would be expected and where appropriate should be included in the “Detailed Budget” section under ‘Other Direct Costs’. Additionally, applicants should demonstrate that all potential recruiting locations have been considered and the research is deliverable to those areas.

Please see the NIHR INCLUDE Guidance for more information about how to include under-served groups effectively.

Please also see Promoting equality, diversity, and inclusion in research for further help.

5.4 Summary of patients/service users/carers/public as research participants

The successful recruitment and retention of study participants is strategically important for the NIHR. If your proposed study involves patients/service users/carers/public as research participants please use the following bullet points to summarise their characteristics and what would be expected of them throughout the project. The potential burden on study participants can then be understood as well as whether or not the proposed strategies are practical, inclusive and feasible. Please also signpost to where further information on these points can be found in the detailed project plan and application.

Points to cover:

• Inclusion and exclusion criteria to help ensure that certain groups were not being excluded without justification
• Recruitment method and consent process to ensure it is practical and fair
• Type and content of participant information materials
• Overview of research methods to capture data from participants and their frequency e.g.questionnaires/tests/intervention/focus groups/ interviews
• Study participant support to consider how drop-out and issues of participation would be handled/helplines/ other access arrangements required
• Methods for sharing study progress and findings with study participants
• Payments, rewards and recognition for study participants.

Applicants may find the SPIRIT 2013 statement a useful resource when preparing their protocol.

5.5 Risks and mitigations

The project plan must include a realistic assessment of the main challenges to overcome, and propose appropriate steps for the mitigation of risks. This should include main technical and clinical barriers, management of stakeholders, and issues with potential adoption. Consider also potential challenges associated with ethical approvals, if applicable. Ensure that these risks are considered when defining milestones (the go/no- go points for your project). Furthermore, you should set out the measurements of success you intend to use to evaluate the risks of delivering this project research and what contingencies you will put in place to reduce or eliminate each risk or its impact.

You may upload a risk register as one of your documents.

NOTE: A risk is defined as any factor that may delay, disrupt, or prevent the full achievement of an objective. Typical areas of risk within a project might include staffing, resource constraints, technical constraints, data access, timing, management, and operational issues (please note that this list is not exhaustive).

Upload a Gantt chart

It is mandatory to attach a Gantt chart indicating a schedule for the completion of work, including the timing of key milestones and deliverables.

6. Ethics/Regulatory approvals

It is a requirement for this Programme that all products have UKCA or CE mark prior to application submission.

If applicable, outline any ethical issues associated with the proposed project and the arrangements for handling them. If there are no plans to obtain an ethical review, this must be clearly justified. Note that the work outlined in your application/protocol must adhere to the UK Framework for Health and Social Care Research.

7. Dissemination, outputs and anticipated impact

The purpose of this section is for the applicant to describe the planned outputs of the project, how these will be communicated and to whom, and, including anticipated timescales, how the project may lead to short and longer-term impacts. NIHR understands that the impact of any research may take time to be realised and will likely involve other funders, institutions and sustained efforts in practice. NIHR also recognises it may be difficult to provide definitive answers or guarantees on longer-term impacts. However, applicants are invited to consider various aspects of pathways and how the likelihood of impact can be maximised. This includes considering what outputs are produced, how these can be best connected to the health and/or social care environment, what efforts are likely to be needed beyond the project and what impacts the project is seeking to achieve.

7.1 What do you intend to produce from your project?

Please provide brief details of each anticipated output. The term ‘outputs’ refers to any tangible product of the project. Outputs can include but are not limited to: conference presentations or other workshop events; publications (academic or otherwise); guidelines (clinical, service or otherwise); other copyright (e.g. questionnaires, training aids, toolkits, manuals, software, etc.); new or improved design of medical devices or instrumentation; new or improved diagnostic; trial data that could be used to shape or influence a healthcare market or government; potential new health or social care intervention. One required output for this programme is guidance to support future innovators on this pathway; details should be included here.

7.2 How will you inform and engage patients/service users, carers, NHS, social care organisations and the wider population about your work?

Describe who you need to communicate with within this project, and your plans for engaging relevant audiences. For impact, it is unlikely that simply making outputs available will be sufficient. Please consider, and outline the active approach you will take to engaging key parties, or identify the process you will use to identify them and formulate an engagement plan.

7.3 What do you think the impact of your project will be and on whom?

Describe the impacts you aim to achieve as a direct result of the project and those which are anticipated longer term. Please consider how any smaller, more immediate effects may mature over time into larger scale or more significant effects, and the steps by which this may be achieved. As far as possible, indicate anticipated timescales for these benefits and a quantitative estimate of their scale. Impacts may include, but are not restricted to - patient/service user, carer benefit; health and/or social care staff benefits; changes in NHS or care services (including efficiency savings); commercial return (which could contribute to economic growth); public wellbeing.

7.4 How will you share the progress and findings of your project with study participants?

What strategies will you use to keep your study participants informed of the progress of your project and the findings? Consider the ethical implications of informing study participants and also what the most accessible methods could be, such as newsletters, leaflets, webpages, social media and where relevant different languages and formats. The Health Research Authority Publication and dissemination of research guidance provides advice on the information participants of trials should receive at the end of the study.

8. NHS implementation, spread and adoption strategy and commercialisation plans, including barriers

It is important to ensure continued progress towards widespread adoption after this project. Provide an overview of how the selected product(s) can be further adopted and commissioned, including additional funding or support required and what barriers might be faced.

8.1 How will your product(s) enter our health and care system or society as a whole?

Please consider providing a small analysis of the market size for the product(s) in the NHS and other markets, also in view of market changes. Describe the process by which the product(s) will enter the health and/or social care environment, including how they will be acknowledged, selected and introduced for use in the health and care service or wider society. Outline the expected timescales for regional and national spread. Where possible, consider how the work will be able to be adopted and implemented long term. Please describe the proposed route to market (commercial or non-commercial) for your outputs. Describe who is needed to take it forward and support a sustainable spread of the innovation in care pathways (current or redesigned), and the relationship you currently (or propose to) have with these parties. If the product(s) are likely to be commercially exploitable, please include details on how you plan to develop this.

For each product, this section should clearly describe the intellectual property (IP) and commercialisation strategy, with details of the following:

• Any existing IP and ownership arrangements, including patents or patent applications that are relevant to the project.
• The procedure used to evaluate the freedom to operate (FTO) position.
  • Describe any FTO searches conducted to date and details of who carried them out. If no search has been conducted to evaluate FTO, explain your rationale.
  • List all related IP not owned by any of the applicants, including details relating to third party IP licensing requirements.
• Any IP which will be produced or improved during the project by any of the partners.
• How any new IP generated through the project will be recognised, captured, managed and utilised, providing information on who will lead on dissemination and/or commercial exploitation.

8.2 What further funding or support will be required if this project is successful?

Consider what investment or support may be needed at the end of this project (e.g., from NIHR, Government, charity or industry) to maximise impact. Not all projects will require this but if so, plans should be linked to the responses in the questions above.

8.3 What are the possible barriers for further adoption and implementation?

Describe the difficulties which may be faced in achieving widespread adoption. These may be difficulties you will face yourself, or challenges faced by those in the implementing context (e.g., clinicians)

1. What are the key current and future barriers to uptake of any likely output or innovation directly in the health and care service, through commercial exploitation or other means, e.g. potential regulatory, financial, organisational hurdles?
2. What are the challenges for getting your product(s) implemented in terms of acceptability, accessibility and feasibility? How will you address these?

Section 8: Patient and Public Involvement

Please describe how patients/service users, carers and the public have been involved in developing this proposal. Max 350 words

You should describe who has been involved and why this is appropriate, what role(s) they have played and what influence or change has happened as a result of their involvement

Please describe the ways in which patients /service users, carers and the public will be actively involved in the proposed research, including any training and support provided. Max 350 words

a. PPI approach, management and support

• Explain why your approach to patient and public involvement is appropriate for this proposal. In your description you will need to say who will be involved and why.
• Please use this opportunity to describe how you plan to manage and coordinate the patient and public involvement activities in your project.
• Describe how you will support and enable patients/service users, carers, the public and members of relevant communities to contribute to your project (e.g. access, payments, training).
• We would also encourage you to outline plans for capturing, evaluating and reporting the impact of patient and public involvement activities.

Patients, carers, service users and the public can be involved in every stage of a project, from developing a proposal through to dissemination and evaluation. More resources to support the design of your PPI are available in our guidance on the NIHR website.

b. A summary of PPI activities

Please provide a summary below of the proposed PPI activities embedded throughout the project lifecycle. Please clearly signpost to other sections of the ‘Detailed Project Plan’ where the PPI is described further in relation to the relevant project stage e.g. dissemination, intervention design, data collection, and analysis.

In rare cases where proposals do NOT involve patients and the public, clear justification must be provided. Max 200 words

Section 9: Detailed Budget

Justification of costs

Provide a breakdown of research costs associated with undertaking the project and provide justification for the resources requested, including the following:

1. staff costs,
2. travel, subsistence and conference fees
3. equipment (including lease versus purchase costs)
4. consumables
5. patient and public involvement, engagement and participation
6. other direct costs
7. dissemination costs
8. indirect costs

For help with estimating PPI costs please see the NIHR Payments Guidance for researchers and professionals.

You should indicate here how this project will potentially benefit the NHS and/or public health and social care sector. For example, where appropriate, describe the likely cost savings or benefits in terms of numbers of patients treated, treatment times, service users or carers supported etc.
You should describe the value for money of the conduct of the proposed project.

Please also provide justification for the NHS Support and Excess Treatment costs detailed in the SoECAT. If there are no NHS Support or Excess Treatment Costs associated with the research you must explain why you think this is the case.

Detailed Budget Breakdown

The finance section should provide a breakdown of costs associated with undertaking the research as described in the proposal. Please refer to the associated ‘How to complete the finance form’ or short video for guidance about how to complete this section of the application form.

Programme specific information

There is no upper or lower set limit for the size of these awards. Applicants should request a budget appropriate for the generation of the evidence required by the NICE EVA programme for a product, or products under a topic, to progress towards/achieve a full NICE evaluation, as well as any further evidence generation required by commissioners to encourage increased uptake and use of technologies within the NHS or care settings. All funding requests will be scrutinised to ensure they are eligible within the appropriate guidelines (see core finance guidance).

When justifying staff costs you should also provide the % amount of time input of each member of staff and link this to the specific area/work package of the proposed study where this input will be taking place.

General information

The information entered in this section should provide an analysis of the total funds requested to undertake the project proposed and should be based on current prices. These costs will be used to assess value for money.

It is in your best interest to undertake a thorough, realistic and accurate costing. You must provide a clear and full justification for all costs including NHS costs. You must also ensure that you include all costs including those required to secure good research management.

• Costs must be provided at current prices. An adjustment for inflation will be made annually thereafter at rates set by the Department of Health and Social Care. Whilst allowances for incremental increases should be included on the form, nationally or locally agreed pay increases should be excluded.
• Years should be calculated starting from the anticipated start date of the proposed project. For example, if your project is expected to start on 01 October 2024 then its second year starts 01 October 2025.
• Further itemisation of costs and methods of calculation may be requested to support the application at a later date.
• Payments will be made to the contracted organisation only and the contracted organisation will be responsible for passing on any money due to their partner organisation(s).
• Appropriate sub-contracts must be put in place for any element of the research which is to be paid to another organisation.
• NHS support costs, including costs for Social Care research, are funded via Clinical Research Networks. Researchers should contact their local NHS R&D department initially and, if they are unable to help directly or if there is no local NHS R&D department, contact the Local Clinical Research Network (LCRN) senior manager for advice on NHS support costs. Further details about LCRN contacts are available on the NIHR LCRN website.
• All applications are expected to have appropriate NHS, Higher Education Institutions (HEI), commercial and other partner organisation input into the finance section of the application form.
• Non-commercial led Awards (e.g., NHS, HEI etc.) will be paid via BAC transfer payment schedules. The NIHR will release funds net of VAT as Research and Development is considered VAT exempt. There are some cost items within an application which may incur VAT, such as equipment or subcontractors. If the applying organisation is unable to claim back the VAT on these items (e.g., maybe they are not VAT registered) then applicants can charge the gross value to the application.
• Commercial led awards will be paid via invoicing. It is up to the company to decide if it is appropriate to apply VAT on the invoice. If the company decides to apply VAT, then DHSC will pay the invoice and claim back the VAT. We recommend that applicants seek advice from VAT experts within their organisation before applying.

Please note that whilst the applicable percentages will be used to calculate the maximum grant payable, the programme reserves the right to award a grant for less than this maximum where it is considered appropriate.

Information on different types of organisations

Higher Education Institutions (HEIs)

Higher Education Institutions (HEIs) should determine the Full Economic Cost (FEC) of their work using the Transparent Approach to Costing (TRAC) methodology. For HEIs, up to 80% of FEC will be paid, provided that TRAC methodology has been used.

NHS bodies and other providers of NHS services

For applications where the contractor is an NHS body or provider of NHS services, up to 100% of direct costs will be paid.

Commercial/other partner organisations

If you are a commercial organisation/consultancy, please fill in direct costs and commercial indirect costs. Indirect costs should be charged in proportion to the amount of research staff effort requested on the funding application form. Up to 100% of costs will be paid.

If you are another partner organisation (e.g. charity or NGO), please fill in direct costs and other partner organisations' indirect costs. Indirect costs should be charged in proportion to the amount of research staff effort requested on the funding application form. Up to 100% of costs will be paid.

Direct costs

These are costs that are specific to the project, which will be charged as the amount actually spent and can be supported by an audit record. They should comprise:

Staff costs

This section presents an overview of salary and associated on-costs for the applicant(s) contributing to the project, including normal salary increments broken down individually.

Salary costs (apply to years)

This section specifies the annual costs of each applicant contributing to the project. You should now allocate the individual staff member costs to each year of the project, allowing for increments. Use current rates of pay, and build in any known annual increments (again at current rates). You will not be able to claim for pay awards retrospectively, once your project is underway.

Travel, subsistence and conference dissemination costs.

This section includes journey costs, subsistence and conference fees. Where applicable, you will need to include the travel and subsistence costs of your project advisory group, steering committee and/or data monitoring & ethics committee. Travel and subsistence costs relating to dissemination should also be included here, as should costs relating to overseas travel.

Journey costs

Enter the total cost of transport for all journeys for destination/purpose. If travel is by car, apply your institution’s mileage rates (however this should not exceed HMRC approved mileage allowance payments, which is 45p per mile for the first 10,000 miles and 25p thereafter).
Travel by the most economic means possible is encouraged. NIHR programmes do not usually fund first class travel.

Subsistence

Subsistence covers accommodation (if necessary) and meals associated with the travel, excluding any alcoholic beverages.

Conferences

Where national or international conference costs are included, a statement naming the conference or purpose of travel and the benefit to the project must also be made; failure to adequately justify your attendance at a conference will mean the programme will not fund this cost.
For projects of up to five years, the programme will usually fund up to a maximum of two international conference attendances (two people attending one conference or one person attending two conferences). There are no limits on the number of UK conference attendances.

Equipment

Essential items of equipment plus maintenance and related costs not included as part of estates should be input in this section. These can be lease or purchase costs.

• The purchase cost of pieces of equipment, valued up to £5,000 excluding VAT, will be considered.
• Pieces of equipment costing more than £5,000 to purchase will usually need to be leased. Where applicants are leasing equipment with a purchase price of more than £5,000, a comparison of leasing versus purchasing costs must be provided in the ‘Justification of Costs’ section.
• Items of equipment valued at £250 or more must be itemised separately; however grouping same type equipment is permitted.
• Costs of computers are normally restricted to a maximum of £800 each excluding VAT and a statement of justification must be included in the relevant ‘Justification of Costs’ section for any purchase above this limit.
• Equipment must exclude VAT, but if your organisation is unable to reclaim/recover the VAT on a piece of equipment, you should check the box ‘VAT cannot be reclaimed’.
• You will need to seek expert advice from the organisation purchasing the equipment regarding its VAT status. If you check the ‘VAT cannot be reclaimed’ column, VAT at 20% will automatically be calculated into the overall cost of that item.

Consumables

This section includes non-reusable items specific to the project. Please itemise and describe the requirements fully (e.g. postage, stationery, photocopying). These items should be project specific, not just general office costs which should be covered by indirect costs.

Patient and public involvement

Please itemise and describe fully the costs associated with patient and public involvement. These are likely to include individual travel, out of pocket expenses, payment for time and any relevant training and support costs. Costs related to study participants should not be itemised here.

If voluntary, charity or community groups are supporting the project via activities such as facilitating contact with potential participants, hosting research activities or providing advice, an adequate budget must be included to compensate for their time and resources.

For further information on budgeting for involvement, please read the NIHR Payments Guidance for researchers and professionals.

Other direct costs

These are costs, not identified elsewhere, that are specifically attributed to the project. For example, costs associated with the use of research facilities, external consultancy costs, costs associated with inclusivity (which may include, but are not limited to justified translation of research participant material into other relevant languages), computer licensing, recruitment and advertising costs.

Please note that for organisations claiming indirect/overhead costs, costs such as recruitment of staff, and general training (e.g. in common IT packages) are costs that should be covered by the indirect costs element of the award being sought and should not appear in this section.

The NIHR will consider supporting reasonable patent and legal costs arising from the project during the period of the award only. The NIHR will not support retrospective patent costs incurred by the applicant prior to NIHR funding and will not be liable for any costs post-completion of the project.

If external consultancy costs are included in this section they must be fully justified in the ‘Justification of Costs’ section. Please specify the hourly rate and the number of hours and note that consultants must not be people who are already employed by the applicant’s institution. If they are, any costs should be entered as direct costs in the ‘Details of Posts and Salaries’ and ‘Annual Costs of Posts’ sections.

Dissemination Costs

Open access costs

Applicants should no longer include open access costs as part of their Detailed Budget.

From the 1st of June 2022 all eligible awards contracts issued across NIHR Programmes, NIHR Personal Awards and NIHR Global Health Research Portfolio will have an Open Access Envelope allocated to them on top of the award value, which is ring-fenced for open access costs of peer reviewed research articles that arise directly from the research funded by the award in question.

Further information can be found by reading the Open Access Funding Guidance.

Other dissemination costs

Any large costs should be further detailed with a breakdown of constituent parts or a timescale profile of the costs. Meetings to share best practice, training events and events to disseminate research findings must be run at the lowest possible cost with minimal catering. ‘Conferences’ which are described as such are not eligible for funding.

Indirect costs/overheads

Indirect costs will be charged in proportion to the amount of research staff effort requested on the award.

They comprise:

• General office and basic laboratory consumables
• Premises costs
• Library services/learning resources
• Typing/secretarial
• Finance, personnel, public relations and departmental services
• Usage costs of major research facilities
• Central and distributed computing
• Charge out rates for shared equipment
• Cost of capital employed

NHS bodies or other providers of NHS services indirect costs

NHS indirect costs cannot be claimed through NIHR/DHSC programme funding. NHS bodies or other providers of NHS services have been allocated NIHR Research Capability Funding (RCF) to contribute to the cost of hosting NIHR/DHSC-supported research. For more information please visit the RCF webpage.

HEI indirect costs

Total HEI indirect costs must be fully justified. HEIs are permitted to claim estate and other indirect costs. These costs are calculated on the basis of TRAC methodology. Proposals from other types of institutions/organisations should leave this section blank.

• HEI indirect costs are based on the number of full-time equivalent research staff working on the research and the indirect/estates charges set by an institution.
• Where staff from more than one HEI are working on the research there may be different indirect/estates charges for each one. Please list each institution on a separate line.
• Please note HEI indirect costs cannot be claimed on shared staff costs.

The applicant(s) should consult their HEI finance departments for the appropriate figures to include in the estate charges and other indirect cost section.

Commercial/other partner organisation indirect costs

Commercial/other partner organisations can claim indirect costs which are the costs of resources used by the project that are shared by other activities. Please seek advice from your finance department about the appropriate cost for this section.
Total Commercial/other partner organisation indirect costs must be fully justified.

NHS support and treatment costs (incl. excess treatment costs/savings)

Please be aware that the award does NOT include NHS support and/or treatment costs. These costs, including costs for Social Care research, are funded via Clinical research Networks and should be detailed in the Schedule of Events Attribution Tool (SoECAT) (see below for further details).

However, the committee will take NHS support and treatment costs into account when considering the value for money of the project. It is important that you consider these costs and discuss them with the NHS bodies or providers of NHS services involved in order to avoid any delay in commencing the project.

Applicants should contact their local NHS R&D Department initially and if they are unable to help directly, or if there is no local NHS R&D Department, contact their Local Clinical Research Network (LCRN) for advice on NHS Support Costs. Further details about LCRN contacts are available online at ‘Clinical Research Network’.

When considered necessary by the LCRN AcoRD specialist, a Schedule of Events Cost Attribution Tool (SoECAT), detailing NHS support and/or Treatment Costs, needs to be completed and uploaded as part of the application.

NHS support costs

These are the additional patient care costs associated with the research, which would end once the R&D activity in question has stopped, even if the patient care service involved continues to be provided. These might cover items such as extra patient tests, extra in-patient days and extra nursing attention. Researchers should contact their local NHS R&D department initially and, if they are unable to help directly or if there is no local NHS R&D department, contact the LCRN senior manager for advice on NHS support costs. Further details about LCRN contacts are available on the NIHR LCRN website.

NHS treatment costs

Please read the guidance on excess treatment costs Online SoECAT guidance prior to completing your application.

These are the patient care costs that would continue to be incurred if the patient care service in question continued to be provided after the R&D activity has stopped. In determining NHS treatment costs you must assume that the patient care service being assessed will continue even though there may be no plans for it to do so. Where patient care is being provided which differs from the normal, standard, treatment for that condition (either an experimental treatment or a service in a different location from where it would normally be given), the difference between the total treatment costs and the costs of the “usual standard care" (if any) constitutes excess treatment cost/saving, but is nonetheless part of the treatment cost, not an NHS support or research cost. These costs should be determined in conjunction with your NHS body or provider of NHS services and their commissioners.

Please note: Social care studies are eligible for Clinical Research Network (CRN) support, it does not just apply to NHS-based research, and researchers should speak to the CRN and include support costs where relevant. For the purposes of social care studies ‘treatment costs’ should be interpreted as ‘intervention costs’ and should be included in the proposal when needed. Further guidance on support and ‘treatment’ costs can be found on the Online SoECAT guidance

For further information, please see the attributing the costs of health and social care research and development (AcoRD) guidance

Uploading a Schedule of Events Cost Attribution Template (SoECAT) form

Please be aware that if your planned project includes the recruitment of participants, your application should be accompanied with the Funder Export from the online SoECAT, obtainable via the NIHR Central Portfolio Management System (CPMS). This online version replaces the previous Excel version of the SoECAT, which will no longer be available for applications.

In order to create a SoECAT, you will need to create an account in CPMS. After creating the account, you will need to login to CPMS to activate this account. If any assistance is required in creating the account, please refer to our user guide. Once your account has been created and is active, you can proceed.

Guidance for the completion of the SoECAT by the applicant is present in the online tool to assist at each page and stage of the application process and further details can be found on the Online SoECAT Guidance page.

There is also an Online SoECAT Guidance Module which includes video tutorials and linked resources (an NIHR Learn account is required to access and enrol onto the module) and a helpful Study Representative - Online SoECAT Top Tips infographic.

Please note that completion of the SoECAT may not be necessary when applying for funding to support: overarching programmes with no specific research study protocol, infrastructure, fellowships, anything where the grant is to be used for direct employment of a member of staff or purchase of an asset, and data or diagnostic reviews where recruitment data is not collected. Such applications should be submitted with an explanation added to the ‘Justification of Costs’ section.

More information on the SoECAT form is available on the NIHR website:

Online SoECAT Guidance

Section 10: Management and Governance

Is Clinical Trials Authorisation required?
Yes / No

Does your project require ethics approval?
Yes / No

If yes, has ethics approval already been obtained?
Yes / No

Section 11: Uploads

Mandatory:

• A list of references cited in the application (maximum 3 pages A4).
• A copy of the Evidence Generation Plan completed by NICE
• A completed Schedule of Events Cost Attribution Tool (SoECAT)

If involving a Clinical Trials Unit:

• CTU letter of support.

The following file(s) are considered non-mandatory to submission; please number your files and attach:

Supporting documentation, including logic models, flow diagrams, pathway map, risk register, pictures, charts, letters of support, papers in press etc. No more than five separate files are permitted. The total file size should not exceed 6Mb (this includes the SoECAT form and the Gantt Chart uploaded earlier in the form). Total file sizes larger than this may not be considered as part of the submission. All supporting documentation must be uploaded with a clear and concise filename description, preceded by a numbered ‘Appendix’ reference

Section 12: Administrative contact details

Please provide the details of an administrative lead as a secondary point of contact for any queries relating to the application, should it be supported.

NOTE: This person does not need to be a co-applicant.

Section 13: Research and Development office contact details

Please provide the contact details and job title of a person in the R&D office so that we are able to notify them of the outcome of this application including any associated feedback.

NOTE: This person does not need to be included as a co-applicant.

Section 14: Acknowledge, review and submit

Conflicts of interest declaration

Please declare any conflicts or potential conflicts of interest that you or your co-applicants may have, including any facts that, should they come to light at a future date, could lead to a perception of bias. Include any relevant personal, non-personal & commercial interest that could be perceived as a conflict of interest. Examples include (this list is not all encompassing) secondary employment, consultancy, financial or commercial gain (pensions, shareholdings, directorships, voting rights), honoraria, etc. In the case of commercial sector involvement with the application or the study, please state clearly the relationship to ownership of data, access to data, and membership of project oversight groups.

Agreement to terms and conditions

As Lead Applicant, please tick the box to confirm that the information given on this form is correct and that you will be actively engaged in this research and responsible for its overall management. In addition, you will accept responsibility for ensuring that the host institution and interested parties are kept informed.

Ticking this box constitutes an electronic signature of the Lead Applicant with regard to this application

Checklist of information to include when submitting a NIHR i4i & OLS Real World Evidence application

Applicants should click the checkboxes to indicate that they have included the necessary information prior to submitting their application.

• Appropriate and relevant involvement of patients/service users, carers and the public
• A good quality plain English summary
• A clear description of team member roles and contribution
• A clear scientific abstract
• A full and accurate detailed budget breakdown
• A clear justification of costs/value for money
• A clear Detailed Project Plan outlining the study design, methods, dissemination etc.
• A CTU letter of support if required (document upload)
• Gantt Chart (document upload)
• References (document upload)
• Evidence Generation plan following NICE EVA (document upload)
• Completed Schedule of Events Cost Attribution Tool (SoECAT)
  
  

Support for Applicants and Awardees

Support with research design and forging partnerships is available to all prospective applicants through the NIHR research support services and wider, detailed below. All prospective applicants are encouraged to engage with these services at the earliest opportunity.

• NIHR's Research Support Service - support on all aspects of developing and writing a funding application. *
• NIHR's Business Development Team - help with finding and making great partnerships to strengthen your work.
• NIHR Medtech and In vitro diagnostics Co-operatives (MICs) - can help to build a multi-disciplinary team to work collaboratively and ensure the right generation of evidence to support adoption in the NHS. HealthTech Research Centres (HRCs) have been commissioned to replace MICs from April 2024.
• NIHR Applied Research Collaboration (ARC) - support applied health research and research on implementation of health and care evidence into day-to-day practice.
• Health Innovation Networks (formerly Academic Health Science Network (AHSNs)) – support developing real-world evaluation, roll-out and adoption
• InSites Programme - help with finding NHS collaboration sites among the NHS InSites peer network.

* Please note that the RSS service is only available to applicants based in England. Applicants with a project partner based in England are able to access the service, but if you are based in the UK but outside of England, and are not partnered with an organisation based in England you may wish to explore the below services. The NIHR Business Development Team is available to all UK- based applicants and you may wish to contact them in seeking a partner based in England.

• Applicants from Scotland may access NHS Scotland Innovation Hubs and/or NHS Research Scotland
• Applicants fromform Northern Ireland may access The Northern Ireland Clinical Research Network
• Applicants from Wales may access Health and Care Research Wales

Once awarded, the Data for R&D Team within NHS England’s Transformation Directorate will be able to provide signposting to relevant NHS data and organisations who will be able to support awardees in generating evidence.