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Artificial Intelligence Award - Frequently Asked Questions

 

Contents

Application process

How does the Artificial Intelligence in Health and Care (AI) Award competition work?

Please note that the process and timelines vary across Phases 2-4.

The application process is run in 2 stages:

At Stage 1, applicants to all phases complete the Stage 1 application form. Proposals must meet all phase-specific award specifications and funding prerequisites to be considered for review (see Guidance for Applicants for full details). Applications that do not meet these essential requirements will be rejected at this stage. Eligible applications will be reviewed against the AI Award assessment criteria and selected applications will be shortlisted and invited to submit a Stage 2 application. Phase 3 and 4 applicants are particularly welcomed if submitting proposals within the following highlight areas:

  • self-management of long-term conditions
  • diagnostic support
  • improving operational/system efficiency
  • Supporting elective recovery

Stage 1 Outcomes
All applicants will be notified of the outcome but due to the volume of applications we may not be able to provide feedback to unsuccessful applicants at Stage 1.

A Stage 2 application form is to be submitted and will be subject to external peer and public review as well as panel review. Applicants will be invited to present their project and respond to questions during the panel meeting.

How can I find out whether my application is within remit or which phase to apply to?

Please refer to information on the AI award webpage and the Guidance for Applicants. You may only apply to one phase per product. If you are still unsure your proposal is within remit, you may complete an enquiry form with details of your proposed project (this is solely for your information, not a requirement). For general questions, please call us on 020 8843 8272 or email enquiries@ai-award.info

If I apply to one phase but the Panel determines it is more relevant for another phase, will it be automatically transferred?

We will not be able to automatically transfer applications between phases. As such, you should pay careful attention to the entry and exit criteria (under Phases, entry points and fundable activities in the Guidance for Applicants) for each phase. If you are unsure, you may submit an enquiry form.

My application is not covered by one of the focus areas, am I still eligible to apply?

Yes. Self-management of long-term conditions, diagnostic support, improving operational/system efficiency and supporting elective recovery are focus areas for Phases 3 and 4, but applications covering all areas of AI that address an unmet health and/or social care need are eligible. See Guidance for Applicants for further information.

How do I submit an application?

Applications must be made through the online application portal. An example Stage 1 application form is available on the NIHR website, however, please note that this is for demonstration purposes only and may not be used to submit your application. Further information is provided in the Stage 1 AI Application Form Guidance. The ‘System Help’ document found on the application portal’s web pages also provides extensive step by step instructions on how to use the portal.

Can I submit more than one application?

You may only submit one application per product. Whilst an applicant may submit (or be a co-applicant on) multiple different applications, we encourage you to submit your strongest application. If you do submit more than one application, the differences and synergies between the applications must be made absolutely clear in your proposals. Furthermore, you should make sure you have the resources in place to support all applications, should they all be successful.

What is the deadline for applications?

The deadline for Comp 3 Stage 1 applications for all phases is Tuesday 7 September 2021, 1:00pm.
Late submissions will not be accepted unless there is a technical fault of the application portal.

How will applications be selected for funding?

All submitted applications will be reviewed against the AI Award assessment criteria and assessed by a multidisciplinary expert group of selected assessors and a final assessment panel. Funding recommendations will be ratified by the Department of Health and Social Care, NHSX and NHS England and NHS Improvement, subject to sufficient funds.

Are assessment criteria weighted?

No, selection criteria are not weighted.

How important is patient and public involvement and engagement (PPIE)?

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 for all phases and is included as part of the assessment criteria. For further information or support, please see the NIHR website, guide on the definition and role of the designated PPI lead in a research team, or contact your local Research Design Service.

How important is it to focus on health inequalities?

The AI Award has a statutory duty to show due regard to reduce health inequalities, therefore, applications which demonstrate that their AI Solution has the potential to reduce health inequalities will be considered favourably.

When will I find out if my application has been successful and what is the latest acceptable date for the project to start, if funded?

Please see our website for up-to-date information regarding application outcomes and deadlines. You should be realistic about your proposed start date taking into account the necessary contracting and staff recruitment that has to occur prior to starting your project. Once awarded, we will negotiate an appropriate project start date with you.

What happens after I have been awarded AI Award funding?

Due diligence will be performed and contract will be signed. Standard contracts can be found on the sign a contract page of the NIHR website (we reserve the right to amend contracts following review).

If you are a screening programme then you will be required to go through the government’s review of the evidence relating to the introduction, modification and cessation of national population screening programmes. More information can be found in the UK National Screening Committee (UK NSC) review of the evidence relating to the introduction, modification and cessation of national population screening programmes.

For Phase 4 winners, due diligence is likely to involve NHSX funding a NICE Medtech Early Technical Assessment (META) Tool. You will also be introduced to an independent evaluation team that NHSX will ask you to work with as a condition of the Award. The purpose of the evaluation is to fill evidence gaps and accelerate local adoption and national adoption (via NICE guidance or UK NSC endorsement of the product class). These independent evaluations will be published by NHSX on their website once complete. We will discuss the merits of independent evaluations for Phase 3 winners on a case-by-case basis.

We expect the process of due diligence, contracting and evaluation scoping to take 7 after the award is confirmed.

Is UKNSC involved in reviewing applications which may impact screening programmes?

The UK National Screening Committee (UKNSC) is an independent scientific advisory committee that sets criteria for appraising the viability, effectiveness and appropriateness of a screening programme for all the four countries of the UK on the introduction or modification of screening programmes. The first use of AI would be a major modification to a screening programme. The UKNSC has a published process for considering programme modifications. The UKNSC reviews classes of tests not individual products, therefore, it is not able to directly advise on specific ongoing evaluation projects. Public Health England’s (PHE’s) group of expert advisors is working with the AAC to ensure the evaluations meet the needs of the current screening services including workflows, acceptability and feasibility. But note, PHE expert advice for a project should not be taken as confirmation that the UKNSC will provide approval.

What activities will be conducted by the Technology Specific Evaluation Teams?

AAC anticipates 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 clarify which activities they will conduct to prevent double-funding of activities across Technology companies and TSETs.

We expect core TSETs activities to include:

  • Leadership and PMO requirements for the real-world evaluation (e.g. IG 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. We will provide separate guidance on indicative financial envelopes for the evaluation budgets and note that prospective studies and RCTs cost requirements will be higher both for design and execution phases.

How many projects will be funded?

The AI in Health and Care Award will deploy £140m over three years. In the first competition, 42 projects were funded across the phases at just over £50m. There is no set amount to be awarded during Competition 3, rather it will depend on the quality of applications submitted.

Can AAC provide applicants with NHS partners to work with on a Phase 3 or 4 proposal if we do not have partners in place yet?

You are encouraged to contact partners and potential sites as soon as possible (see further guidance on Site Selection) but if your application is successful then the Accelerated Access Collaborative, working with NHS England and NHS Improvement, can provide support and link you up with appropriate NHS organisations.

What is your 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 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).

How should we choose sites to test, evaluate, and/or implement our technology?

Applicants should choose sites with populations or characteristics that avoid selection bias and improve the likelihood that NICE will review the research evidence produced from the AI Award favourably, as detailed in Chapter 6 of Developing NICE Guidelines: the manual. The characteristics include, but are not limited to:

  • The epidemiology of the clinical condition in the UK.
  • The typical case mix of patients at sites.
  • Relevance to strategic demands set out in the NHS Long Term Plan.
  • The availability of the required technology needed to use the AI Solution.
  • The skill mix of practitioners at the sites
  • Risk of health inequalities being exacerbated

To test the external validity of the AI Solution, at least one site should be a site that the AI Solution has not been deployed in before. Applicants should also consider sites in the devolved nations in order to show the ability to deploy in different health and care systems.

For additional guidance and support with site identification, see the Site Selection Guidance or contact your Local Clinical Research Network.

What is the expectation we should have of host sites?

It should be clear to organisations that there are requirements for sites. These include:

  • Site(s) will involve and engage patients, the public and practitioners (health and care professionals) at all stages of its work, and this will be evidenced and measured.
  • Appropriate data sharing agreements should be established with companies, taking into account any guidance from the NHSX Centre for Improving Data Collaboration and Information Governance Teams where relevant, and drawing on additional support from these teams if required.
  • Site(s) are aware of the resource required to be part of the project – that they will cover all NHS support and treatment costs (including excess treatment costs) associated with the project (please refer to the Finance section of this FAQ for further information).
  • It is not expected that any collaborating site will incur unfunded cost pressures as a result of the collaboration, or will be entered into restrictive commercial agreements with the technology partner covering the post-award period.

Can I re-submit an unsuccessful application to a later call?

Yes, but we suggest that you only do this after reviewing the Guidance for Applicants and acting on any feedback received. 

Will the application deadlines change if there is a COVID-19 wave?

Up-to-date timelines can be found on our website.

Can I apply to multiple funding sources?

You may apply for funding for the same project to multiple funding sources, for example to the NIHR i4i programme and the AI Award, however, you will only receive funding for a particular project once. Parallel applications should be clearly stated on your application form.

Who should I contact if I have any questions?

If you are unsure your proposal is within remit, you may complete an enquiry form with details of your proposed project (although this is solely for information, not a requirement). For help with the online application portal, application form and general queries, please email the Programme Management Office at enquiries@ai-award.info

Additionally, NHSX have launched the NHS AI Virtual Hub as a platform setup to allow stakeholders to directly connect rather than just coming through the award. We recommend that you join and you encourage collaborative partners to join for more resources and for engaging with colleagues across the NHS.

Eligibility

What do you mean by AI?

There is no single, universally agreed definition of AI, nor indeed of ‘intelligence’. We are using the definitions described by the AHSN network and further information can be found in the AI Award: AI definition.

Am I eligible to submit an application?

Organisations within the UK are eligible to apply for, and lead, Phase 2-4 applications. Organisations outside of the UK may lead a Phase 3 or 4 application provided they have a UK registered office or a UK health or social care organisation as a joint Lead Applicant. Organisations outside of the UK may also be collaborators on a Phase 2-4 project. Non-UK co-applicants must be reasonably justified and all projects must show a clear health benefit to the UK.

Are applications from organisations in devolved administrations eligible?

The AI Award is open to organisations across the UK, including NHS and care organisations in devolved administrations. Technologies appointed onto the AI Award programme can be deployed in any appropriate UK health or care site.

I am based outside of England, am I eligible to apply?

Organisations within the UK are eligible to apply for, and lead, Phase 2-4 applications. Organisations outside of the UK may lead a Phase 3 or 4 application provided they have a UK registered office or a UK health or social care organisation as a joint Lead Applicant. Organisations outside of the UK may also be collaborators on a Phase 2-4 project. Non-UK co-applicants must be reasonably justified and all projects must show a clear health benefit to the UK.

Can sub-contractors from outside of the UK be used?

Yes, as long as they are justified and the applicants can demonstrate how this will benefit the UK health and social care system.

Are sole traders eligible to apply?

To be eligible to submit an application, you must be classified as a Small or Medium-sized Enterprise (SME) registered with Companies House (or affiliated with a Higher Education Institute, NHS Organisation, Charity, Local Authority or additionally for Phases 3 and 4, a Large company).

I am a pre-startup company, may I apply?

You will need to have registered your company with Companies House prior to submitting your application.

I am part of a large company (i.e not an SME). Can I apply?

Large companies may not apply for Phase 2 funding as a Lead Applicant, however, they may be project partners supporting collaborative projects (for example through in kind contributions).

Large companies may apply for Phase 3 or 4 funding, however, funding may only be received for implementation activities. If you are a large company looking to submit an application to Phase 3 or 4, we welcome your application but will discuss financial contributions during the process of assessment and selection.

Can Large companies be co-applicants or collaborators on Phase 2 applications?

Large companies can support the Lead Applicant as a collaborator or as a co-applicant but they cannot benefit from receiving any of the award money. It is also necessary for a formal collaboration agreement to be agreed to ensure that the terms amongst the collaborators are clear from the outset, especially regarding the ownership of foreground IP and the arrangements for commercialisation of the technology (with an appropriate level of royalties available to the principal applicant).

Can a consortium apply?

Applications must be submitted by a single Lead Applicant. Where appropriate and justified, it is acceptable for the application to be led by joint Lead Applicants but for application/contracting purposes, the joint Lead Applicant will be counted as a co-applicant.

My company is a registered charity, can I apply?

Yes, registered charities are eligible to apply.

Can a Clinical Commissioning Group (CCG) submit an application?

Yes, Clinical Commissioning Groups are responsible for commissioning services for their local area, so as a health service provider they are eligible to apply.

Can an Academic Health Science Network (AHSN) be a co-applicant or subcontractor?

An AHSN can act as a co-applicant or subcontractor provided their role is clearly defined and justified. Any costs allocated to the AHSN must be justified as being for services that are outside the remit for which they are funded by NHS England and NHS Improvement and Office for Life Sciences.

As an SME, can I work in collaboration with other companies?

Yes, you can work in collaboration with other companies.

Do joint Lead Applicants need to be from different organisations?

No, joint Lead Applicants can be from the same or different organisations.

I work for an organisation developing a technology for social care applications, am I eligible to apply?

Yes, organisations that develop or provide social care products or services may apply. This includes Small and Medium-sized Enterprises and Local Authorities.

Can the proposal consider an AI based enhancement of an existing commercially deployed medical product to address new areas of unmet need in the NHS?

Yes, the application would be eligible.

Application form

Is the application form the same for Phase 4 as Phases 2-3 as they were different in Competition 1?

Yes, we have streamlined the process so the same Stage 1 form is used for all phases. 

Can supporting images/figures be embedded in the application form (i.e. in the Detailed Project Plan)?

Yes, although images should not be used to circumvent the word count. We recommend that you check the PDF of the application before submitting to see it's rendering correctly and as you expect.

Do AI Health and Care Award applications require a specific referencing style?

Please use Vancouver or Harvard style format.

What potential is there to amend the research plan and costs between Stage 1 and Stage 2?

The Stage 2 application may change, for example, to accommodate the Stage 1 feedback, or in response to information in the guidance document. However, a very large increase in time or cost would need significant justification within the application and applicants should keep in mind that panels will consider value for money when assessing applications.

Where can I find more information on what to include as NHS support and treatment costs?

Please contact your Local Clinical Research Network.

Does the commercialisation strategy have to include adoption into the NHS?

The commercialisation strategy should include adoption into the NHS or care setting but may also cover other elements such as private sales.

Is there any advantage of submitting an application with an NHS host rather than a university host?

The host or Lead Organisation should be the main partner driving the project forward. We appreciate that researchers may sometimes have dual affiliations; if you are in doubt about which organisations should be leading please contact the AI Award team at enquiries@ai-award.info.

For Phase 3 applications, a minimum of 2 different organisation types must collaborate, one must be an NHS organisation. For Phase 4, applications with clear engagement with sites for deployment will be looked upon favourably, however it is not essential at Stage 1.

Is it an advantage or disadvantage if our novel device comes from a commercial partner?

It is acceptable for a product to have originated from a commercial or non-commercial partner.

Is there preference to deliver projects using labour rather than subcontractors?

There is no preference as such, we would expect you to use whoever is the best placed / has the most expertise to deliver the work. If you are subcontracting, you would need to justify why you are using subcontractors (i.e. you don't have the expertise in your team, etc.)

Is a Health Economic analysis required for every proposal?

A strong health economic outcome will be crucial in ensuring the innovation is taken up into the NHS or care setting. For Phase 2, applicants should include a work package which will allow you to build a health economics model. For Phase 3 we would expect the application to include a model that you would be able to populate with your data. For Phase 4, we would expect you to generate real world health economic evidence. We strongly recommend you work with a health economist on such work.

A strong health economic outcome will be crucial in ensuring the innovation is taken up into the NHS or care setting. At Phase 1, we would expect the application to consider the issue, looking at the anticipated research pathway and start to build a model to populate once you are able to generate some data. For Phase 2, applicants should include a work package which will allow you to build a health economics model. For Phase 3, we would expect the application to include a model that you would be able to populate with your data. For Phase 4, we would expect you to have generated real world health economic evidence, in the form of a full health economics assessment. We strongly recommend you work with a health economist on such work. Your AI Award application may include further health economic research that you would like to undertake through the award (but please do not include costs for such work as these will be covered by your TSET)

Do applications need to list deployment sites?

Applications are not required to list sites at Stage 1, however, early engagement is recommended. At Stage 2, you would be expected to demonstrate that engagement has occurred with the target site(s) (i.e. provide letters of support). The AI team will take a holistic view of the application if not all of the required engagement has been evidenced. Further information on site selection is available in the Site Selection guidance.

Legal

What is a Small and Medium-sized Enterprise (SME)?

The Companies Act 2006 defines an SME as any organisation that satisfies two or more of the following requirements:

  1. Turnover not more than £36 million
  2. Balance sheet total not more than £18 million
  3. Number of employees not more than 250

Who owns the Intellectual Property (IP) generated by a project?

In general, foreground IP will be owned by the lead organisation. There will be situations where foreground IP might be owned by collaborating organisations. This will be agreed on a case-by-case basis during contract negotiations. Written consent should be requested from the Authority (not unreasonably withheld) prior to any Commercial use of the Foreground IP or Arising Know How or Research Data from the Award, as per the standard contract.

What research contract will be used if my application is successful?

Standard research contracts for Higher Education Institutions (HEIs), NHS and commercial organisations for Phase 2 Awards, as well as a standard contract for Phase 3 and 4 Awards, can be viewed on the sign a contract page on the NIHR website. We reserve the right to amend contracts following review.

Finance

For further details on AI Award costs, see AI Finance Guidance.

Is it possible to give guidance on the upper limit of individual application budgets?

For Phases 2-4, there is no formal upper limit as we encourage well considered applications, taking into account all aspects required to develop a product that is ready for the next step. Indicative range for Phase 2 and 3 funding is £500k-1.5m and £1-7m for Phase 4 (depending on number of sites and project duration).

Are SMEs eligible to apply for 100% of eligible costs?

As with other NIHR awards such as i4i, SMEs are eligible for up to 100% of full economic costs and there is no requirement for match funding.

As a university, should I use Full Economic Costing (FEC)?

Yes, the same rules apply as for all NIHR competitions, Higher Education Institutions (HEIs) should determine the Full Economic Cost (FEC) of their research using the Transparent Approach to Costing (TRAC) methodology and 80% FEC will be paid. Please read the AI Finance Guidance for more detailed information.

Should applicants enter the full economic cost (FEC) or the 80% requested?

At Stage 1, applicants should enter the estimated total project costs that will be requested (including Higher Education Institutions (HEI) at 80% FEC). At Stage 2, further breakdown is required and applicants from an HEI should enter the FEC ensuring they select ‘HEI’ under ‘ORG TYPE’ and the form will automatically calculate 80%.

Can overheads/indirect costs be included in project costs?

Overheads may be included for Higher Education Institutions (HEIs) and Small and Medium-sized Enterprises (SMEs) with justification. NHS Organisations should recover overheads through the Research Capability Fund. Please read the AI Finance Guidance for more detailed information.

Can the cost of capital equipment be included within an application?

Capital equipment costing up to £5k can be included.

If an organisation is VAT registered, should we include VAT charges in our application?

Equipment and other items or activities incurring VAT must exclude VAT, but if your organisation is unable to reclaim/recover the VAT on an item/activity, you should check the box ‘VAT cannot be reclaimed’.

Applicants should seek expert advice regarding an item or activity's VAT status. If you check the ‘VAT cannot be reclaimed’ column, VAT at 20% will automatically be calculated into the overall cost of that item.

NHS Support and treatment costs

For all NIHR projects, regardless of the lead organisation, NHS Support and Treatment costs are funded via Clinical Research Networks. Researchers should contact their local NHS R&D department initially and, if they are unable to help directly or if there is no local NHS R&D department, contact the Local Clinical Research Network (LCRN) senior manager for advice on NHS support costs.

Is a SoECAT form required for each Lead/co-applicant?

One SoECAT is required per application at Stage 2, this should cover the full set of partners.

Does this funding stream attract Research Capability Funding (RCF)?

All NIHR programmes (including Competition 3, Phase 2 AI Awards,) where the Funding Agreement is held by an NHS organisation, are eligible to attract RCF. NIHR RCF is allocated by Department of Health and Social Care to research-active NHS organisations and it is for the recipient organisation to determine how to use its allocation. The costs included in your AI Award application should reflect all eligible costs that the project will need. For further information, see the Research capability funding webpage and the AI Finance Guidance.

Can the award be used to fund a PhD study?

A PhD student can be employed as part of your application, but the award does not cover fees for PhD study.

During the project, how are funds distributed to collaborators?

The lead organisation will be paid in arrears and is responsible for distributing funds to collaborators in line with local finance processes.

Can the funding be split with a university outside of the UK, or should the funding remain within UK organisations?

International co-applicants are allowed, but justification would need to be provided as to why this organisation is best placed to fulfill the role over other UK organisations. The main applicant will be required to set up a UK subsidiary or a UK based bank account in order to receive payments.

Can Stage 2 costs change from those submitted at Stage 1?

The Stage 2 application, and therefore costs, may change from Stage 1, however, a large increase in cost would need significant justification within the application and applicants should keep in mind that Panels will consider value for money when assessing applications.

If the project duration is increased in the Stage 2 application, should the budget also increase proportionately?

Costs can be amended if the duration of the application is amended. However, applicants should keep in mind that all the changes, regardless of phase, should be fully justified.