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Artificial Intelligence in Health and Care Award - Guidance for Stage 2 Application Form

Contents

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.

Section 1: Application Summary Information

Lead organisation

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.

NOTE: If your organisation does not appear on this list, please contact enquiries@ai-award.info.

Lead organisation details (Companies only)

Please provide the following information about your company:

  • 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

Please also state if you have had previous private or public funding, and the amount.

Lead applicant

Please provide contact details for the lead applicant.

Project title

The project title should state clearly and concisely the proposed AI solution and what it does (30 words maximum). 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.

Project duration

Ensure you include sufficient time to complete all aspects of the research including applications for regulatory/ethical approvals and patient recruitment, where required.

  • Phase 1: Product and clinical feasibility projects may be 6 - 12 months in duration.
  • 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.

Please note that the maximum funding available for Phase 1 projects is £150,000.

There are no set budget limits for Phase 2-4 projects.

Please ensure you complete and upload an AI Award Finance Form under Section 7: Detailed Project Plan.

Total NHS Support & Treatment costs or external (not NHS) intervention costs

Enter the total amount of NHS Support and Treatment costs, or external intervention costs, associated with this proposal.

Please ensure you complete and upload a 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 Schedule of Events Cost Attribution Tool (SoECAT) is required regardless of whether your project includes NHS Support and Treatment costs.

Further details about LCRN contacts are available on the LCRN website.

Section 2: The Team

Applicant and team details

Specify the role of the lead applicant as well as all 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. 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, collaborators normally provide specific expertise on particular aspects of the project but who do not share in the responsibility for the delivery of the project.

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 Team’ section of the ‘Detailed Project Plan’.

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.

If your proposal does not include implementation or evaluation sites, please select ‘0’.

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 National Institute for Health Research (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.

1) aim(s) of the project
2) background to the project
3) work plan
4) patient and public involvement
5) dissemination and anticipated outcomes

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.

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 and NIHR guidance on improving inclusion of under-served groups in clinical research useful.

1) Background
2) Aims and Objectives
3) Work plan and methods used
4) Timelines for delivery
5) Anticipated Impact and Dissemination

Section 6: Changes from first stage

Please list the feedback received at first stage 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

Using all of the headings in the order presented below, please use this section to clearly explain your proposed project. You should ensure that the information is accurate, succinct, clearly laid out and sufficiently evidenced.

The Opportunity

NHS unmet clinical need & market pain

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 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. Please report market size, any related trend or forecast, patient population affected, NHS cost burden, and state of the art.

Phase 3 and 4 focus areas

If you are applying in Phase 3 or 4 under one of the focus areas including triage (notably triage for ophthalmology, dermatology and cancer care), imaging, screening and intelligent operational automation, 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 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

Describe the impact the project aims to achieve. Impact may include but is 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)

In accordance with the NHS Net Zero initiative to reduce the NHS’s carbon emissions, please additionally outline the environmental impact of your AI Solution.

The Proposed Innovation

Provide a clear description of your AI solution covering comprehensive details of its functionality, structure and intended use. Provide details of any existing proof of concept, pilot, efficacy, usability or validation data for the proposed innovation and that of the AI component, if different to that of the proposed innovation. Include details of any training datasets that were used and clarify if the AI component has been validated on an independent dataset. Describe all relevant standards you are adhering to (i.e.the AI Code of Conduct for data-driven health and care technology (for artificial intelligence systems used by the NHS), the NICE Evidence Standards Framework for digital health technologies, the NHS Digital Standards for commissioning or developing Personal Health Records) and outline the relevant approvals in place or the stage in the regulatory process your technology has achieved (i.e. if Phase 3 or 4, whether your technology is CE/UKCA marked or when you anticipate it will be, if required).

Explain the level of innovation of the proposed technology and the intellectual property position, accompanied by a review of the existing evidence surrounding similar products that may be in development or already be on the market, and any relevant ongoing research in the area of focus. A consideration of the proposed barriers to clinical/social care adoption must also be clearly articulated, including details on the interoperability of the proposed innovation with existing NHS systems, as required.

Work project plan 

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).

For Phase 4 applicants, an independent Technology Specific Evaluation Team (TSET) will be appointed to support delivery and analysis of high quality evidence generation from the real-world deployment of the technology. Please set out work packages as currently conceived, and for successful applicants, the Accelerated Access Collaborative will hold tailored conversations with each applicant 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:

When designing your study, please consider how you can reduce health inequalities by ensuring that your study population reflects the target population of individuals who are affected by the relevant condition(s), that the measures you use to evaluate the efficacy and effectiveness of your AI solution are of relevance to the target population, and that your AI solution is designed and delivered in a way that is acceptable and accessible to a broad range of people. Please provide details confirming that your study meets these criteria (as applicable) and justify and explain any exclusions, for example by completing an Equality Impact Assessment. For more information, please refer to the NIHR INCLUDE guidance.

Other helpful links:

The Team

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, for any reason, salary costs of members of the team are not going to be sought via this application, please outline here how their contribution will be supported.

For Phase 4 applicants, TSETs 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. Therefore, Phase 4 applicants can highlight where the project team would benefit from additional independent evaluation expertise provided by the Accelerated Access Collaborative.

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.

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.

Intellectual Property (IP) and commercialisation strategy

All background and any potential foreground IP arising from the project must be described in the application. An initial freedom to operate opinion must 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.

Please include details of the intended market, barriers to entry, and competitor analysis 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 the company, and/or any income already being generated. Market opportunities, both domestic and global can be explored.

Dissemination and NHS adoption strategy

Please describe the planned outputs of the research and how they may lead to short and longer-term NHS,patient and public impacts. 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 benefit; healthcare staff benefits; changes in NHS or social care services (including efficiency savings); commercial return (which could contribute to economic growth); public wellbeing.

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.

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. Detail what current and future barriers to adoption are likely to be encountered, and a strategy for overcoming them. 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.

Video Pitch (Phase 1 only)

The 3 minute video presentation should complement your application. We do not expect professionally produced videos (you can use a smartphone), however, please ensure the visual and audio is of good quality. Please provide a link to the video file for the Innovations Programme Management Office to download. Any videos exceeding 3 minutes in duration will be truncated at 3 minutes.

Phase 2-4 Awards will be invited to present their proposal during the Stage 2 meetings week commencing 26 April 2021.

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.

Finance form

Please attach a copy of your 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 1 AI Awards are capped at £150,000.

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)

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.

The SoECAT and more information can be found excess treatment costs page on the NIHR website, along with guidance for completing the Schedule of Events Cost Attribution Template (SoECAT).

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.

For Phase 2-4 proposals, evidence must 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. You can find further resources to support the design of your PPI in our list of PPI resources for applicants to NIHR research programmes.

PPI Lead

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. Examples of the activities a PPI lead might undertake can be found in our guidance on the definition and role of the designated PPI lead in a research team.

A 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: Other supporting roles - Signatories (electronic)

The following supporting roles from the host organisation must be added to the application:

Director of Finance or equivalent

If the lead organisation, e.g. a Company, does not have these supporting roles, these fields should be completed with the details of the person fulfilling these functions.

Electronic signatures

On assigning these contacts an email will be sent to each by the system requesting they approve the application and confirm the content by checking the boxes below. Ticking this box constitutes an electronic signature of the supporting role for the full application.

We recognise that the lead applicant of the application may also be the Director of Finance. Within your RMS account you are able to switch between these accounts. This guidance on electronic signatures for research applications outlines how you can switch between roles to fill out the relevant sections of the RMS application form. Please do not create two RMS accounts.

The Lead Applicant will also be required to tick a check box to indicate that they have read and understood the terms on which he/she has been nominated as Chief Investigator for this proposal along with the associated documentation and accept this role.

Once these contacts have approved the application you will be able to proceed to submit.

No wet ink signatures are required for this application.

Section 10: 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 file name 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
  • 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 11: 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.

Section 12: 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’.