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Artificial Intelligence in Health and Care Award - Guidance for Stage 1 Application Form

Contents

Published: 30 October 2020

Version: 1.1 - June 2021

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Please be aware guidance may change for future competitions

This guidance is for completing an application form for Stage 1 of the Artificial Intelligence in Health and Care Award (AI Award). The guidance applies to all phases of the competition.

Please jump to ‘Stage 1 Application Form’ for details of what to include in your application.

Please see also the AI Award competition guidance and finance guidance.

How to apply

Applications must be made through the Research Management System (RMS) online application portal. A template application form may be downloaded from the website, however, please note that this is for information purposes only and may not be used to submit an application.

To submit an application, you must complete all the relevant sections of the online form available within the online application portal. Please be aware that all co-applicants must have accounts with the PMO RMS online portal in order to be added to the application and confirm and approve their participation.

The ‘System Help’ document found on the application portal’s web pages provides extensive step by step instructions on how to make use of the portal.

Registration

Only registered users of the application portal can apply. Applicants new to using the application portal should register as a new user. Once logged into your account the application portal home page is the starting point to create applications, access co-applications and to update contact information and professional details. All co-applicants must also be registered.

Managing my details

Lead applicants and co-applicants can manage their basic contact information and curriculum vitae (CV) through the ‘Manage my Details’ link on their application portal home page. Lead and co-applicant contact information and CV details are integrated by the application portal into the relevant fields during the application process. Please note that only lead applicant CV details are mandatory at Stage 1 while basic contact information is required for co-applicants. Lead applicants should ensure entry of their ORCID iD number. At Stage 2, lead and co-applicant CV details are mandatory.

Creating an application

The lead applicant must initially create the new application. Clear instructions on how to start a new application can be found in the ‘System Help’. The research team can collaborate with the lead applicant to edit the content in the application by being invited to be a co-applicant through the co-applicant section of the application form.

The lead applicant can use the search tool to find co-applicants and then to invite them to join the application. Co-applicants must have an account before they can be searched and added to the application by the lead applicant. The application portal will automatically dispatch an email inviting the co-applicant to confirm their participation in the application. Co-applicants can then decide whether to accept the invitation and consent to the application being submitted jointly in their name. They will need to log into the application portal and follow the links to ‘Confirm’ their involvement on the co-application summary page. Once confirmed, the co-applicant will be granted access to edit the online application form.

All co-applicants must not only ‘Confirm’ but also ‘Approve’ their invitation to participate in the application electronically on the co-application summary page in advance of the submission deadline.

Completing an application

From the application summary page, the application can be edited by clicking on the ‘Edit’ button. The different sections of the application form can then be accessed via the list of hyperlinked buttons on the left-hand side of the application portal webpage. You can move from page to page either by using the ‘Previous’ and ‘Next’ buttons, or using the list on the left-hand side of the web page.

Most questions are associated with contextual help buttons and clicking on them will open up pop-up windows containing brief guidance notes that supplement the published guidance for applicants. It is strongly advised that applicants refer to the published guidance first and then use contextual help as they complete and review each question as contextual help is not designed to replace it. Mandatory questions are flagged with a red dot.

The system will prevent your co-applicants accessing your application at the same time as you. This stops applicants and co-applicants inadvertently making changes to the same part of the application at the same time and overwriting each other’s work.

For more details on the electronic approvals required from official representatives of the host organisations in advance of submitting your application, please refer to the published guidance for applicants.

Remember to save your work

You will be prompted to save your work if you leave the browser in application editing mode but we recommend you save your work regularly to minimise the risk posed by any local computer or internet problems. You can save and return to the application form as often as you like prior to submission.

Exiting and returning to work on your form

Should you wish to exit your form, you will be prompted to save your work and you can return at any time; simply log in using your username and password and select ‘My Applications’ from the menu. You will then be presented with a list of all the applications you are currently involved with as well as providing details as to their stage in the submission process.

Validation and submission of the form

The lead applicant can review the progress of their application at any time by selecting the ‘View/Print’ option on the application summary page to generate the application as a PDF File.

When the application form has been completed, the lead applicant must use the ‘Validate form’ tool within the online application form. The validation step is a check run by the application portal to assess whether all the mandatory questions contain information. It will provide a list of links to any parts of the form where corrections or additional content are needed.

Once the application has been validated successfully and no further corrections are needed, the lead applicant can submit the application by clicking on the ‘Submit’ button on the lower right-hand side of the application summary page.

Following submission

A programme specific reference number will be assigned to the application once it has been submitted. After the relevant competition round closes, the application will automatically enter the process of being considered for funding.

If you have any questions regarding your application, please email enquiries@ai-award.info.

Stage 1 Application Form

Section 1: Application Summary Information

AI Award Phase

Please select the appropriate phase based on the current development stage of your AI solution:

  • Phase 2: Product development and clinical evaluation
  • Phase 3: Real world testing
  • Phase 4: Initial health system adoption

A description of the individual phases including minimum eligibility requirements can be found in the Guidance for Applicants.

Justification for AI Award Phase

Provide evidence of how the proposed technology meets the minimum criteria for the phase to which you are applying. Specify the entry and exit points of the proposed technology, and that of the AI component, if different to that of the proposed technology. Provide details of any regulatory approvals received or their stage of preparation (e.g. CE/UKCA marking). 

A description of the entry and exit points of each phase is available in the Guidance for Applicants.

AI solution category

Please select the appropriate category that best describes your technology from the list below:

  • Health promotion & prevention
  • Diagnosis & treatment
  • System efficiency

A description of these categories can be found in Figure 1 in the Guidance for Applicants.

Lead organisation

Provide details of the organisation who will be the contractor if the project is funded. For Phase 2, this may be a UK based Small and Medium-sized Enterprise (SME), Higher Education Institution (HEI), Charity, Local Authority, NHS organisation or other provider of NHS or social care services. For Phases 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. 

If your organisation is not on the list, contact enquiries@ai-award.info.

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.

Proposed start date if funded

Note this should be 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 contract negotiations 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 in particular, patient recruitment, where required.

Phase 2-4 projects can be a minimum of 12 months up to a maximum of 36 months in duration.

Estimated project costs

Please enter the total project costs requested, not including any NHS support and treatment costs or external (not NHS) treatment costs. If partnering with NHS sites, ensure that all project-related costs incurred by the site are covered in the estimated project costs.

There are no set budget limits for Phase 2-4 projects (although indicative costs are £500k-1.5m for Phases 2 and 3, £1-7m for Phase 4 depending on scale of plans and number of sites).

Further information on application finances can be found in the Finance Guidance.

Estimated NHS support & treatment costs or external (not NHS) intervention costs

Enter the total amount of NHS support and treatment costs or external (not NHS) intervention costs associated with this proposal if applicable. These costs will not be met by the AI Award but will be taken into account when assessing the overall value for money provided by the proposed project.

Section 2: Lead Applicant Details

All information in this section is auto-populated from the ‘Manage my Details’ section within the Lead Applicant’s PMO RMS account. Ensure this is up-to-date prior to submission. You will need to create an ORCiD iD on the ORCiD website

Section 3: 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.

%FTE commitment

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.

Joint Lead Applicant

Where appropriate and justified it is acceptable for the application to be led by joint Lead Applicants. Where this applies, please select ‘Add Joint Lead Applicant and %FTE commitment’

Information will be populated from the selected joint lead’s ‘Manage my details’ section within their PMO RMS account.

Justification for Joint Lead Applicant and role in the project

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. Please also provide a brief overview of the Joint Lead’s role in the project.

%FTE Commitment

This refers to the percentage of the Joint Lead’s time that they will commit to this project.

NOTE: For application/contracting purposes, the joint lead applicant will be counted as a co-applicant.

Co-Applicant role and %FTE

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

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

Co-applicants are those individuals with responsibility for the day to day management and delivery of the project and can include patients, carers and service users. 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 do not share in the responsibility for the delivery of the project.

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 team member who is able to manage the PPI plans and related activities. Please see our list of examples of the activities a PPI lead might undertake.

IMPORTANT: Colleagues will need to register to participate as co-applicants after which they must both confirm and approve their participation; the application cannot be submitted without doing so.

A maximum of 10 co-applicants is permitted (which includes the joint lead applicant if listed).

Section 4: Plain English Summary

A plain English summary is a clear explanation of your development work. 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 entrepreneurs, 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 and/or members of the public in developing a plain English summary.

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

a) aim(s) of the project
b) background to the project
c) work plan
d) patient and public involvement
e) 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 in our plain English summaries guide.

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

Section 5: Project Plan

Using all of the headings in the order presented below, please use this section to clearly explain your proposed project. Schematics, tables, illustrations, graphs, and other types of graphics can be embedded to clarify the project 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 not seen by reviewers.

As this is the main part of your application which will be considered by the reviewing panel, you should ensure that the information is accurate, succinct, clearly laid out and provides sufficient detail.

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/or social care services, and how this work would fill a demonstrable evidence gap. Please quantify your response where possible. Please also provide a description of how your AI solution will support NHS Long Term Plan, NHSX strategic priorities and/or wider government priorities including the Industrial Strategy grand challenges or resource efficiency. Please report market size, any related trend or forecast, patient population affected, NHS cost burden, state of the art.

Benefit to patients, the NHS and the wider population

Provide a clear case (quantifying where possible) how the proposed device, technology or intervention will change clinical or social care practice and provide benefit to patients, the public and/or service providers.

Benefits may include but is not restricted to:

  • Patient & public wellbeing (reduced mortality or morbidity, 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 return on investment (reduced service delivery costs, improved organisation/service cost control, reduced treatment cost to patient, reduced staffing cost)
  • Social and policy benefits (change in policy, change in professional guidance, improved awareness)

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
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, supporting elective recovery, please specify which one under this heading, and explain how your project fits the remit of the focus area.

The proposed innovation

Provide a clear description of the proposed innovation and its AI or learning component, including details of its functionality, structure and intended use. You must clearly articulate why your innovation constitutes AI and what stage of development it is at. 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. Provide regulatory information including:

  • The intended purpose of your product. ('Intended purpose' means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials.)
  • Does your product 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 question 3. 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.

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 already be on the market, and of any relevant ongoing research in the area of focus. A consideration of the proposed barriers to clinical/social adoption must also be clearly articulated, including details on the interoperability of the proposed innovation with existing NHS or care systems.

Work plan

List individual work packages, including deliverables and milestones, the key risks and how these will be mitigated. Work packages may focus on, for example, technical, clinical or commercial aspects of the project. Example activities that may be included in each phase are described under Phases, entry points and fundable activities in the Guidance for Applicants. Include a description of the main hurdles to be overcome technically, clinically and commercially. Detail the key risks to your project (including technical, clinical, regulatory, 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). Some examples of activities that may be included can be found in the Guidance for Applicants.

A Gantt chart indicating the schedule for the completion of work, including the timing of key milestones and deliverables must be attached in the supporting information

Adoption strategy

Present a specific strategy for adoption of the technology into the NHS or social care, including the proposed NHS or social care sites where the technology would be evaluated (if applicable; see our site selection guidance for further information). Describe the process by which the technology will enter the healthcare 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 adoption.

Adoption sites

If applicable, NHS or social care sites where the technology would be evaluated can be described here. When selecting sites, applicants should consider whether sites demonstrate appropriate:

  • geographical spread
  • mix between urban and rural populations
  • ethnic diversity in populations
  • spread across geographies with high health inequalities

Discussions with sites should be initiated as soon as possible and letters of support will be required from collaborator sites at Stage 2. Further information on site selection is available on the NHS virtual hub.

Team

If necessary, collaborators and sub-contractors may be described in the Project Plan. Collaborators normally provide specific expertise on particular aspects of the project but do not share in the responsibility for the delivery of the project. 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.

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. Clearly delineate the proposed project from other related research, funded from another source, as appropriate.

Patient and Public Involvement

Involving members of the public, patients and service users in the design and management of the research, evaluation or study is a prerequisite of funding and is included as part of the assessment criteria. Please describe how you have involved patients, carers or the public in the development of your proposed innovation, and/or what plans you have to involve them in future development. 

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 provide advice on developing research applications including involving patients and the public and the James Lind Alliance has a step-by-step guide on involvement in research identification and priority setting.

Section 6: Uploads

Uploads must be provided as a Word or PDF document.

Reference list - Attach one single-side A4 page listing references used throughout your proposal.

Gantt Chart - Attach a Gantt chart indicating a schedule for the completion of work, including the timing of key milestones and deliverables

Section 7: 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 updated their information under ‘Manage my Details’ section of PMO RMS
  • 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’.

Please note that your submission will not be considered complete until all applicants have both confirmed and approved the application and the ‘Submit’ button becomes available and is then used.