Published: 29 January 2021
Version: 1.1 - October 2021Print this document
This guidance is for completing an application form for Stage 2 of the Artificial Intelligence in Health and Care Award (AI Award). The guidance applies to all phases of the competition. Guidance will be updated for Competition 3, Stage 2 for Stage 2 launch.
Please see also the AI Award competition guidance and finance guidance.
Please refer to the terms and conditions under which the award will be made prior to applying for funding. These terms will follow the NIHR standard research contract and are broadly non-negotiable. The contract will be concluded between the lead organisation and the Department of Health and Social Care, which will be managed by the NIHR for Phases 1 and 2 and Accelerated Access Collaborative for Phases 3 and 4.
Section 1: Application Summary Information
Provide details of the organisation who will be the contractor if the project is funded.
UK based Small and Medium Enterprises (SMEs), Higher Education Institutions (HEIs), Charities, Local Authorities, and NHS organisations or other providers of NHS or social care services are eligible to apply.
For Phase 3 and 4, non-UK headquartered internationally based organisations and larger companies are also eligible, provided they have a UK registered office or a UK health or social care organisation as a co-lead applicant. Please also review the associated finance guidance and FAQs.
NOTE: If your organisation does not appear on this list, please contact email@example.com.
Lead organisation details (Companies only)
Please provide the following information about your company:
- Company Address
- Company Registration Number
- Company size
- Company status
- Main Business activity
- Any products in the portfolio or in development with synergies with the proposed AI solution
- Business sector
- Annual Turnover
- Existing footprint in the UK (please include information on any sites the technology has been piloted at to date and any existing partnerships, where applicable)
- Previous private or public funding granted, and the amount.
Please provide contact details for the lead applicant.
Project title (30 words maximum)
The project title should state clearly and concisely the proposed AI solution and what it does. Any abbreviations should be spelled out in full.
AI solution category
The most relevant category that best describes your technology:
- Health promotion & prevention
- Diagnosis & treatment
- System efficiency
A description of these categories can be found in table 1 in the Guidance for Applicants.
Proposed start date if funded
Note this should be from 1st of the month regardless of whether this is a working day or not. Please be realistic about your possible start date taking account of the necessary contracting, and staff recruitment prior to starting your project.
Ensure you include sufficient time to complete all aspects of the research including applications for regulatory/ethical approvals and patient recruitment, where required.
- Phase 2: Product development and clinical evaluation projects may be 12 - 36 months in duration
- Phase 3: Real world testing projects may be 12 - 36 months in duration.
- Phase 4: Initial health system adoption projects may be 12 - 36 months in duration.
Total project costs requested
These are the total project costs, not including any NHS support and treatment costs, and for Phase 4 applications, not including evaluation costs either (as you will be appointed an independent evaluation team). There are no set budget limits for Phase 2-4 Awards. To indicate, awards typically range from £500k - 1.5m for Phase 2 and 3 and £1m - 7m for Phase 4 depending on the scale of the plans and number of adoption sites.
Please ensure you complete and upload an AI Award Finance Form under Section 7: Detailed Project Plan.
NOTE: Please ensure this figure matches the total in the offline AI Award Finance Form.
Total NHS Support & Treatment costs or external (not NHS) intervention costs
These are the total NHS Support and Treatment costs, or external intervention costs, associated with this proposal. The AI Award does not fund NHS support and treatment costs but will take these into account when considering the value for money of the proposal.
Please ensure you complete and upload a Schedule of Events Cost Attribution Tool (SoECAT) under Section 7: Detailed Project Plan.
Please contact your Local Clinical Research Network (LCRN) as soon as possible to discuss NHS Support and Treatment Costs. LCRN sign off and upload of a SoECAT is required regardless of whether your project includes NHS Support and Treatment costs.
Further details about LCRN contacts are available on the NIHR LCRN website.
Section 2: The Team
Applicant and team details
Specify the role of the lead applicant as well as any joint lead applicant and all other co-applicants, including the patient and public lead, providing a summary of their expertise and how it will be leveraged in this project. State clearly the particular contribution that each of the applicants will make towards the project (including specific work-packages where appropriate).
Do not include collaborators, who should be listed in the Detailed Project Plan section of the form. NHS or social care sites where the AI solution will be implemented and evaluated should be included in the Implementation and Evaluation Sites section and may also be included in the Detailed Project Plan where relevant.
Please note that 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. In contrast, in this definition, collaborators provide specific expertise on particular aspects of the project but do not share in the responsibility for the delivery of the project.
Please provide the percentage of time that applicants will commit to this project as a percentage full-time equivalent (%FTE).
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 ‘Justification of Costs’ section of the form and can be included under ‘The Team’ in “Section 7: Detailed Project Plan” if necessary.
A maximum of 10 co-applicants are permitted (including joint lead-applicant, if listed).
Joint Lead Applicant
Where appropriate, it is acceptable for the application to be led by Joint Lead Applicants. Justification should be given to demonstrate why more than one person would be required to lead this project and how the additional lead’s relevant expertise adds value.
Public (PPI) 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, 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.
Section 3: Implementation and Evaluation Sites
Where relevant, state the number and names of the sites where you propose to implement and evaluate the AI technology. These can include NHS or social care settings. Please include a letter of support for each site, where possible. Further information regarding the level of site engagement can be included under ‘The Team’ in the Detailed Project Plan as required. More information on the expected level of site engagement is available in the AI Award Site Selection Guidance. Within Phase 4, not all sites listed may be evaluated by your appointed independent Technology Specific Evaluation Team (TSET). You will work with your evaluation team on selecting sites to be evaluated.
Definition of a site: The definition of a site will depend on the type of technology and which of the UK nations it is being deployed in. However, for England, for example, we would like you to use the definition of NHS Trust for secondary care technologies and Primary Care Network for primary care technologies (even if you are only deploying in one hospital within a Trust or one GP practice within a Primary Care Network).
If your proposal does not include implementation or evaluation sites, please select ‘0’. If your proposal includes more than 20 sites, please add 20 here then detail any additional within the ‘Detailed Project Plan’. There is also a limit to the maximum number of documents that can be uploaded and submitted with your application.
Section 4: Plain English Summary
A plain English summary is a clear explanation of your project. Please note that this summary may be up to 450 words maximum.
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 NIHR and other websites.
A good quality plain English summary providing an easy to read overview of your whole study will help:
a) those carrying out the review (reviewers and panel members) to have a better understanding of your proposal
b) inform others about your project such as members of the public, health and social care professionals, policy makers and the media
c) the funders to publicise the research that they fund.
If it is felt that your plain English summary is not clear and of a 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 / members of the public in developing a plain English summary.
When writing your summary consider including the following information, and where appropriate, incorporate how you support and promote equality, diversity and inclusion.
- aim(s) of the project
- background to the project
- work plan
- patient and public involvement
- dissemination and anticipated outcomes
- exit strategy after funding (please see Guidance for Applicants for expected exit points for each phase)
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 5: Scientific Abstract
The scientific abstract should be a clear and concise scientific summary of the Detailed Project Plan.
The following is a list of potential elements / headings that might be included depending on the design of the proposed project. Information on equality, diversity and inclusion should be included where appropriate. Applicants may find the guidance on the EQUATOR Network website useful.
- Aims and Objectives
- Work plan and methods used
- Timelines for delivery
- Anticipated Impact and Dissemination
- Exit strategy after funding (please see Guidance for applicants for expected exit points for each phase)
Section 6: Changes from first stage
Please list the feedback received at Stage 1 and under separate headings indicate what has changed as a result. Please describe and explain any additional changes that have been made to this proposal since the Stage 1 application e.g. in the light of new research.
Section 7: Detailed Project Plan
The Panel requires a deep understanding of what your innovation does, its intended use (and what it is not intended for), regulations that apply, and aspects of the value proposition for which you have (not) collected evidence. It should be noted that a current lack of evidence or limitations will not necessarily detract from your application, particularly given the developmental nature of the Award. However, if the Panel is struggling to understand your innovation, or perceives you do not have a good understanding of these areas, it may reduce their confidence in your application overall. Therefore, we would encourage you to be as forthcoming as possible on the strengths, limitations, and any areas of uncertainty, so that the Panel can assess your innovation in a way that fully recognises the efforts to date to inform a recommendation for funding.
Using all of the headings in the order presented below, please use this section to clearly explain your proposed project against the numbered headings. You should ensure that the information is accurate, succinct, clearly laid out and sufficiently evidenced.
NHS unmet clinical need & market pain
Please clearly state the value proposition(s) for your product and explain how this will be achieved given the product’s intended use. Provide a clear explanation of the health or social care problem to be addressed, the impact on patients as well as health and social care services, and how the proposed work would fill a demonstrable evidence gap. Please report market size, any related trend or forecast, population affected, NHS/care cost burden, and state of the art.
The population affected is the specific group of patients or service users that your product is intended for. You should consider the prevalence and incidence of the disease/condition/situation; the description of the disease/condition/situation, including severity or treatment stage and the presenting symptoms; population characteristics (for example, is it suitable for adults only, people who are ambulatory, or have a particular condition?); whether your solution is intended for use with any pre-specified groups of patients or service users, or more than one group of patients or service users, where appropriate. Please quantify your response where possible.
Alignment with NHS Long term plan, NHSX or wider government priorities, Phase 3 or 4 focus areas
Please also provide a description of how your AI solution will support the NHS Long Term Plan, NHSX strategic priorities and/or wider government priorities including the Industrial Strategy grand challenges.
Phase 3 and 4 focus areas
If you are applying in Phase 3 or 4 under one of the focus areas including self management of long-term conditions, diagnostic support, improving operational/system efficiency or supporting elective recovery, please specify which one under this heading, and explain how your project fits the remit of the focus area.
Benefit to patients, the NHS and the wider population
Provide a clear case of how the proposed device, technology or intervention will change practice and provide benefit to patients or public (such as reduced mortality or morbidity, improved quality of life, reduced misdiagnosis, and improved patient/service user outcomes and experiences) or benefit the NHS and/or social care services (such as improve operational efficiency, efficacy or clinical decision making). Potential cost savings for the NHS or social care should also be provided.
Please note that your AI solution must have the potential to be cost effective and meet at least one of the following criteria
- Improvement in patient and / or service-user outcomes
- Improvement in patient and / or service-user experience
- Improvement in operational efficiency
The Proposed Innovation
Innovation and intended use
- Provide a clear description of your AI solution including comprehensive details of its functionality, structure and intended use (e.g. what type of algorithm, rule-based or other). You must clearly articulate why your innovation constitutes AI and what stage of development it is at. Please also outline the current clinical/care/operational pathway as well as the proposed future pathway with your technology embedded.
- Please describe the intended purpose of your innovation. 'Intended purpose' means the use for which the technology is intended according to the data to be supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials.
- Does your innovation qualify as a medical device? 'Medical device' here means medical device, in vitro diagnostic medical device, or active implantable medical device per the law (stated in the bullet point below). Please justify your response with respect to the intended purpose of the product.
- If your device does qualify as a medical device, please state the device classification under either Directive 93/42/EEC, Directive 98/79/EC, Directive 90/385/EEC, Regulation (EU) 2017/745, or Regulation (EU) 2017/746. Please stipulate the primary rule used to derive the device classification.
- Please outline the relevant authorisations in place, or the stage in the regulatory process your technology has achieved.
- If Phase 3 or 4, you must state whether your technology is CE/UKCA marked or when you anticipate it will be, if required. Please note, all CE mark devices will need UKCA mark by 1 January 2023.
Product development and evidence (as relevant to your development stage)
- Please describe all relevant standards you have, or will have, adhered to during product development, including training and validation.
- Clearly provide details of datasets that were used in developing the product, including:
- Number of samples or data points, and any relevant inclusion / exclusion criteria
- The degree of heterogeneity across the dataset, including but not limited to:
- Demographic composition of the participants
- Technologies used to obtain the samples / data points
- Settings in which samples / data points were obtained
- Any limitations you have identified in the datasets, and your plans for mitigation
- Clarify if the AI component:
- has been validated on an independent dataset
- how the AI performed against the reference standard in testing, and what reference standard was selected
- Please describe in detail all of the studies you have undertaken to test the performance and / or impact of your product (and that of the AI component if different to that of the proposed innovation). This should include:
- The nature of the study such as if it was a pilot, clinical trial, small-scale proof of concept, retrospective validation, etc
- Details of the Population in the study, including but not limited to: referral route; care setting; demographics of participants; whether cohorts were retrospective and / or prospective
- Clarity on the Intervention, including whether this included the AI innovation proposed for use in the AI Award, or rather a component of it or a different version of the innovation
- Details on the Comparator chosen for establishing relative benefits, why this was chosen
- Outcomes (primary and secondary) and how the product performed against each compared with the Comparator; relating these back to the value proposition
- Limitations and weaknesses of each study, and with these in mind how you would like to use the AI Award to develop further evidence
- Please clearly state the strength of evidence you consider you have gathered for each value proposition; describing it as either ‘none’, ‘limited’, ‘some’ or ‘robust’. Please state which of the studies described above generated the evidence to support this value proposition. You may wish to use a table to convey this.
- NB. We do not expect you to have gathered evidence to support each value proposition as the purpose of the Award is to fund further evidence generation.
- Please explain the level of innovation of the proposed technology and provide a thorough review of the existing evidence surrounding similar products that may be in development or already be on the market. This should include:
- products which aim to make a similar improvement to the health or care system but may have a different mechanism.
- products with a very similar mechanism, which may have the same intended use as yours or have the potential to be applied to your use case
- Please provide a thorough review of any relevant ongoing research in the area of focus.
Patient data use and monitor of patient safety
Describe any known limitations of the data used and algorithms deployed by the AI solution. Include an ethical examination of how the data would be used, and how it would comply with the AI Code of Conduct. Explain how the product’s performance would be validated and how it would be integrated into health and care provision. Demonstrate that security of the data is integral to its design.
Please include details of how you will monitor and report patient safety or data issues, including any recovery plan.
Ethics and regulatory approvals
Outline any ethical issues associated with this research and the arrangements for handling them. If there are no plans to obtain ethical review, this must be clearly justified. Note that work outlined in your application must adhere to the UK Framework for Health and Social Care Research.
The work plan should include the following:
- Aims and objectives of the project
- The individual work packages within your project, including deliverables and milestones (a Gantt chart indicating the schedule for the completion of work must be attached). Work packages may focus on, for example, technical, clinical or commercial aspects of the project.
- A description of the main hurdles to be overcome technically, clinically and commercially.
- The key risks to your project (including technical, clinical, financial and IP risks) and the steps you will take to manage and mitigate these risks. Ensure that these risks are considered when defining milestones (the go/no go points for your project). The reviewers appreciate the challenges involved in developing and implementing AI technologies and welcome an honest, critical review of your plans.
For Phase 4 applicants, an independent Technology Specific Evaluation Team (TSET) will be appointed and funded by Accelerated Access Collaborative to support delivery and analysis of evidence generation from the real-world deployment of the technology. This could include, for example, refining the design, enabling collection, and analysis, of economic evidence generation. Please set out work packages as currently conceived and highlight where you would benefit from additional independent evaluation expertise provided by the Accelerated Access Collaborative. For successful applicants, the Accelerated Access Collaborative will hold tailored conversations with each project team to understand how evaluation and evidence generation requirements can best be met in collaboration with the TSETs.
Every person eligible to take part in research should be offered the same opportunity of taking part in that research regardless of:
- Geographical location
- Gender reassignment
- Marriage and civil partnership
- Pregnancy and maternity
- Ethnicity (you may find the toolkit for increasing participation of BAME groups in health and care useful)
- Religion or belief
- Sexual orientation
- Socioeconomic status
- Access to health or social care
All 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 sample is 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:
In particular and where appropriate, if involving patients/service users, carers as research participants, please also provide key details about how they will be supported, managed and involved (see below)
Summary of patients/service users/carers/public as research participants
The successful recruitment and retention of study participants is important. 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 research project lifecycle. 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 research 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.
It is mandatory to attach a Gantt chart indicating a schedule for the completion of work, including the timing of key milestones and deliverables.
Intellectual Property (IP)
All background and any potential foreground IP arising from the project must be described in the application. An initial freedom to operate opinion should be provided, referencing any third parties’ rights which may affect the implementation of your device or technology. A strategy should be proposed for how third party rights will be managed to allow for further development, implementation and commercial exploitation. Provide details of any new types of IP that may arise during the project, including ownership arrangements and management of the IP.
IP arrangements between collaboration partners, and with consultancies and sub-contractors must be regulated by appropriate agreements. The Lambert Toolkit provides model agreements for collaborations between universities and companies.
Dissemination, commercialisation strategy and NHS/social care adoption strategy
Outputs, outcomes and impact
Please describe the planned outputs of the research and how they may lead to short and longer-term NHS, social care, patient and public impacts. As far as possible, indicate anticipated timescales for these benefits and a quantitative estimate of their scale.
The term ‘outputs’ refers to any tangible product of the research. Outputs can include but are not limited to: conference presentation 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 support a UKCA/CE mark, market authorisation or equivalent; trial data that could be used to shape or influence a healthcare market or government; potential new drug or health or social care intervention.
Impacts may include, but are not restricted to:
- Patient & public wellbeing (improved quality of life, improved safety, improved satisfaction with care, improved independent living, improved health, slowed progression of ill health)
- Clinical benefits (improved accuracy of diagnosis, improved detection rates, reduced false positive/negatives, improved health data quality/availability; improved effectiveness of the therapy, improved availability of the therapy, improved ability to stabilise/manage the condition)
- Staff & service provision benefits (improved staff capacity, improved staff capabilities-knowledge and skills, simplified/improved care pathway, more efficient care pathway, reduced number of procedures, reduced waiting times)
- Economic benefits & commercial ROI (reduced service delivery costs, improved organisation/service cost control, reduced treatment cost to patient, reduced staffing cost)
- Social and policy benefits (reduction in health inequalities, change in policy, change in professional guidance, improved awareness)
Describe how the outputs of the research will be communicated and to whom. Identify key stakeholders, and your plans for engaging them. To realise 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 to disseminate the work.
Commercialisation and adoption
How will your outputs enter our health and care system or society? Present a specific strategy for adoption of the technology into the NHS or social care services. Will the technology likely be overall cost-incurring or cost-saving to the NHS or care setting? Describe the process by which the technology will enter the health or care environment, including how your solution will be acknowledged, selected and introduced for use in the health and care service or wider society. Describe the proposed route to market (commercial or non-commercial) for your technology. Describe who is needed to take it forward and the relationship you currently (or propose to) have with these parties. Please include details of the intended market size as well as details of your sales strategy/channels and marketing plans. Include a pricing strategy. Provide any details of market traction, interested customers and their potential value for your organisation, and/or any income already being generated. Market opportunities, both domestic and global can be explored.
Barriers and enablers
What are the possible barriers for further development, adoption and implementation? Detail what current and future barriers to adoption are likely to be encountered, and a strategy for overcoming them. These may be difficulties you will face yourself, regulatory hurdles, or challenges faced by those implementing the technology (e.g. clinicians/practitioners). Include details on the interoperability of the proposed innovation with existing NHS systems, as required. Where possible, consider how your solution will be adopted and implemented longer term, and what efforts and investment are likely to be needed beyond the project to achieve widespread NHS or social care adoption.
Explain why the group is well qualified to run this project, describing the expertise of the team in health research, technology development and commercialisation. 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 research.
If applicable, include a brief description of the current status of your collaboration with the proposed implementation and evaluation sites listed above (e.g. you have only just completed initial discussions, you have an established partnership, etc.). If sites have not yet been engaged but are required for your proposal, please provide justification and detail how and when you plan on completing this.
Sub-contractors may 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 the existing research support (e.g. funding from other sources) available to the team, which is relevant to this proposal. Clearly delineate the proposed project from other related projects funded from another source.
It is mandatory to upload a completed AI Award Finance Form. For further information, please refer to Finance Guidance. Justification should be provided if costs differ significantly from the Stage 1 application.
Phase 2-4 AI Awards are uncapped. The amount awarded depends on the nature of the proposed work. As a guide, funds required to complete activities to achieve the exit criteria for Phase 2 or 3 may be around £500,000 to £1.5 million, or £1 to 7 million for Phase 4, depending on the complexity of the project and number of sites involved.
Phase 4 Evaluation costs
The Accelerated Access Collaborative will be appointing independent Technology Specific Evaluation Teams (TSETs) to work with the Phase 4 Award winners as part of the Award. The TSETs will be separately funded to carry out their activities and it is therefore important to consider which activities the TSETs may conduct, so as to prevent double-funding of activities across project teams and TSETs. Following the announcement of successful applicants, the Accelerated Access Collaborative will hold tailored conversations with each team to understand how evaluation and evidence generation requirements can be met in collaboration with the TSETs.
We expect core TSET activities to include:
- Leadership and PMO requirements for the real-world evaluation (e.g. information governance and project management, risk management, quality assurance, budgeting, milestone management)
- Data collection activities (preparing template for clinicians to report and input, qualitative interviews, surveys, advice from clinicians to support data collection)
- Analysis and Health Economics (analysis of qualitative and quantitative outputs, data collection, data cleaning, development of a health economic model)
- Reporting (Interim reports and findings, final report)
- Patient and public involvement (engagement activities and analysis of data)
Eligible costs covered by TSET:
- Data extraction and analysis specifically for evaluation: Extraction and analysis of data above and beyond that collected through the normal deployment of the AI technology is an eligible cost covered by the TSET.
- Qualitative work: Costs associated with running group discussion, interviews or anything of this nature would be an eligible cost covered by the TSET.
- Dissemination costs: Things such as publications to peer- reviewed journals; events and other channels to increase impact of work would be an eligible cost covered by the TSET.
- Health Economic Impact Assessment costs: These are eligible costs covered by the TSET.
- RCT and CTU costs: These are eligible costs covered by the TSET.
- Costs of clinical trial registration: If the evaluation is considered research as defined by the UK Policy Framework for Health and Social Care Research, these are eligible costs covered by the TSET.
- Direct incurred costs, this includes: Labour costs for all those contributing to evaluation work; Material costs (including consumables specific to the evaluation project); Capital equipment’s costs; Sub-contract costs;Travel and subsistence;Other costs specifically attributed to the project- These are all eligible costs covered by the TSET.
- Overhead costs, this includes: General office and basic consumables; Administrative Tasks; Finance, personnel, public relations; Costs of capital employed- these are all eligible costs covered by the TSET.
Ineligible costs not covered by TSET:
- NHS costs at sites: Costs associated with deployment of the AI Technology (e.g. costs of the software licenses, IT integration, or training) or collection and curation of data associated with deployment of the AI are not eligible as these costs will be covered by the Phase 4 Award to the technology company.
It is also important to note that TSETs must not cover technology deployment site costs as these are to be funded by the Award.
Schedule of Events Cost Attribution Template (SoECAT)
A SoECAT upload is required for all applications. When considered necessary by the LCRN AcoRD specialist, a completed Schedule of Events Cost Attribution Tool (SoECAT) is required to be uploaded and submitted as part of the application submission. When a completed SoECAT is not considered necessary by an AcoRD specialist, only the front page (study information tab) of the SoECAT needs to be uploaded and submitted as part of the application submission. The SoECAT must be authorised and signed off by an AcoRD Specialist even where there are no excess treatment costs.
More information on the SoECAT form is available on the NIHR website, including:
Section 8: Patient & public involvement (end users involvement)
Please describe how patients/service users, carers and the public have been involved in developing this proposal.
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 result of their involvement.
Evidence should be presented of early engagement with end users (e.g. NICE, clinical commissioning groups, etc.) and their provisional interest in the product.
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.
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 research (e.g. access, payments, training).
Patients, carers, service users and the public can be involved in every stage of a research project, from developing a proposal through to dissemination and evaluation.
Information and resources to assist you can be found on the NIHR website, including: Briefing notes for researchers on how to involve patients/service users, carers and the public, including definition of involvement engagement and participation; and Payments Guidance for researchers and professionals with information on budgeting for involvement.
The Research Design Service provides advice on developing research applications, including how to involve patients and the public, and the James Lind Alliance has a step-by-step guide on involvement in research identification and priority setting.
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 our guidance on the NIHR website.
Summary of PPI activities
Please provide a summary below of the proposed PPI activities embedded throughout the research 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, analysis.
Evaluating impact and reporting of PPI
You will also need to describe how you will record and evaluate the impact PPI has on the project. The level of evaluation should be proportionate to the level and complexity of the proposed PPI activities. The following resources may be useful as they provide different frameworks for assessing impact and reporting PPI:
In rare cases where proposals do NOT involve patients and the public, clear justification must be provided.
Complete/justify as necessary.
Section 9: Net Zero NHS
Our aim is to be the world’s first net zero national health service.
There are two targets:
- For the emissions we control directly (the NHS Carbon Footprint), we will reach net zero by 2040, with an ambition to reach an 80% reduction by 2028 to 2032;
- For the emissions we can influence (our NHS Carbon Footprint Plus), we will reach net zero by 2045, with an ambition to reach an 80% reduction by 2036 to 2039
In accordance with the NHS Net Zero initiative and these two targets please outline the environmental impact of your AI Solution.
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
Please note that all supporting documentation uploaded should be given concise and clear file name descriptions. These should be headed by a numbered ‘Appendix’ and a brief filename description that clearly describes the file (e.g. Appendix_References).
The following attachments are mandatory for all applicants:
- List of references cited in the application
- Gantt Chart
- Completed AI Award Finance Form
- Completed Schedule of Events Cost Attribution Tool (SoECAT)
If claiming Clinical Trials Unit support, the following files are considered mandatory:
- CTU letter of support
The following file(s) are considered non-mandatory to submission; please number your files and attach:
- Any further supporting documentation (flow diagrams, pictures, logic models, trial protocols, equality impact assessment, any letters of support etc.)
No more than 20 separate files are permitted. The total file size should not exceed 6Mb. Total file sizes larger than this may not be considered as part of this submission. We strongly recommend that only .doc or .pdf files are uploaded as some file types are not supported by the system (such as .xls and .zip file types which will not render out into the final version of the application form). Should you wish to upload documents of other file types, we encourage you to check that they appear in the PDF of the application form prior to submission as changes cannot be made after the deadline has passed.
Section 12: Acknowledge, review and submit
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 a case of commercial sector involvement with the application, 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
Section 13: Validation Summary
Please follow these steps as indicated to complete your application submission:
- Validate all mandatory/required fields listed below (that are required to be completed/amended before submitting)
- Check all co-applicants have completed their CV details as appropriate and review the PDF final version for any formatting issues
- Click 'Save and Close'
- Click the 'Submit' option
You will receive an automated email containing the acknowledgment that we have received your application.
If there are no validation requirements above you may be ready to submit the application. To do so 'Save and Close' the application and then click ‘Submit’.