This document provides answers to questions frequently asked about the new Funding At the Speed of Translation (FAST) funding scheme, run by the NIHR Invention for Innovation (i4i) programme.
FAST Pilot
When will the FAST pilot close?
The available budget for the i4i FAST Pilot 2 is approximately £1.5m. The scheme will close on 15 February or earlier if a high number of applications have been received and/or the available funding has been allocated. Applicants are therefore encouraged to apply as soon as possible.
When is the application deadline?
The FAST pilot is open on a rolling basis and has no deadline. Applications may be submitted once they are ready and would be reviewed on a regular basis. Please note, each lead applicant may submit one application and can not re-apply. If awarded, projects must start within 4 weeks of the outcome.
Therefore, applicants are encouraged to consider when it is the most appropriate time for them to submit a proposal. If the project requires a long preparation or setup time, applicants must consider whether the project could start within 4 weeks and whether FAST is an appropriate funding mechanism for this project.
Is the pilot intended for innovations with commercial potential?
The i4i FAST pilot would consider all medical devices, in vitro diagnostics, and Tier C digital healthcare solutions provided that they are within the remit of the i4i Programme. While commercialisation potential is not a requirement, it is one of the most common routes to creating patient benefits.
What is the expected entry criteria for innovations?
The FAST pilot would fund a single question to support the research and development of innovations at Technology Readiness Level 3 (TRL3) at time of application , where proof of concept has been demonstrated as a minimum, through to mature innovations.
What are the eligible organisations to lead a project for the FAST pilot?
Most legal entities registered in England are eligible. These include HEI, NHS providers, SMEs, charities, and local authorities. Large companies and corporations are not eligible.
Can one organisation submit more than one application to the i4i FAST call?
Yes, but there must be clear differences between the projects. Each lead applicant may only submit one application to the pilot call.
Can an applicant submit more than one application to the pilot?
No, each lead applicant may submit one application only and can not hold more than one FAST award at the same time. If unsuccessful, the lead applicant can not submit another proposal to the pilot. A FAST award does not prevent you from submitting to other NIHR or non-NIHR funding programmes.
Can co-applicants be added to applications?
No, a FAST application must be submitted by one lead applicant. If a co-applicant has a role in the research, then their salary can be costed for in the application and their role/input in delivering the single piece of activity described in the application. As these are small funding awards for discrete pieces of activity, we would expect it to be delivered and led by one applicant.
We do not expect for activities outside of the FAST Award to be described in the proposal, as the funding should not be used as supplementary / top-up funding to an additional project or ongoing activity.
Can I re-apply to the pilot?
Lead applicants that were not successful in Pilot 1 can re-apply for Pilot 2. However, they cannot then re-apply to the FAST 2 pilot if unsuccessful.
What is acceptable as demonstrated ‘proof of concept’?
Proof of concept refers to there being enough evidence to convince a reviewer that a technology/intervention has a high potential to be developed into a tangible product. These may include laboratory testing, animal studies, pilot studies on healthy volunteers/patients, peer-reviewed publications. However, these will differ depending on the type of technology.
Are clinical studies funded under the Pilot?
Clinical studies or any work which requires ethical and/or HRA approval or excess NHS treatment and support costs are outside the scope of this Pilot.
Assessments
Are there particular preferences for certain organisations or investigators to lead the projects?
The applications will be assessed based on the criteria described in the guidance for applicants. All eligible organisations will be considered. The applications will be anonymised when reviewed; thus, the outcomes would not be influenced by the type of organisation or the reputation of the lead applicant.
Do I need a collaborator, clinical or commercial partner?
It is not essential to have a collaborator or a clinical partner for the i4i FAST pilot. The lead applicant must ensure that there is the appropriate expertise to deliver the proposed activities within the duration and budget requested, whether this is through its own staff, collaborators, or subcontractors and the relevant clinical input needed for successful project delivery.
Do I need to provide references?
References should be provided where appropriate, particularly to demonstrate the clinical need and proof of concept. You can use the vancouver referencing style and include the full references in a single A4 page attachment.
Finance
What are the eligible costs for the i4i FAST pilot?
Any reasonable costs may be included in the proposal, provided these are justified to support the proposed research activities. This can include (but not an exhaustive list) costs for research staff, consumables for development work, PPI activities, and subcontractors (to conduct a well-overseen and defined piece of work). The finance form should be completed in line with the i4i Finance Guidance to ensure that all costs are eligible.
Who will be responsible for managing FAST funds?
Payments will be made to the contracted organisation only and the contracted organisation will be responsible for passing on any money due to their partner organisation(s). Appropriate sub-contracts must be put in place for any element of the research which is to be paid to another organisation.
Is there a requirement for matched funding from the SME?
There is no requirement for matched funding from SMEs, 100% funding is available for SMEs.
Is there a limit to subcontracting fees or staff to perform administrative activities?
There is no limit on the amount for these activities, provided the costs are justified and below the funding cap. However, FAST provides between £15k to £50k of funding, and is intended to support innovators to answer a specific question to advance their innovation. Therefore, applicants are encouraged to consider whether there are sufficient resources to deliver the proposed activities and high subcontracting or administrative costs may undermine the proposal.
Is NIHR funding classified as state aid?
NIHR awards may be classified as state aid, please refer to our research contract and refer to Schedule D. Please note, contractors are also required to seek NIHR's consent prior to commercialisation of any product that arises from the project (Please see section on Exploitation of Intellectual Property).
How does VAT work?
Non-commercial led Awards (e.g., NHS, HEI etc.) will be paid via BAC transfer payment schedules. The NIHR will release funds net of VAT as Research and Development is considered VAT exempt. There are some cost items within an application which may incur VAT, such as equipment or subcontractors. If the applying organisation is unable to claim back the VAT on these items (e.g., maybe they are not VAT registered) then applicants can charge the gross value to the application.
Commercial led awards will be paid via invoicing. It is up to the company to decide if it is appropriate to apply VAT on the invoice. If the company decides to apply VAT, then the DHSC will pay the invoice and claim back the VAT. We recommend that applicants seek advice from VAT experts within their organisation before applying.
Intellectual Property
Who owns the arising intellectual property?
Non-severable IP will be identified during the contract negotiation process. Ownership of non-severable background IP normally remains with the original owner. Severable IP should be owned by the party best positioned to exploit it. Given the relatively low value of FAST awards, it is expected the foreground IP will be owned by the lead organisation.
When a project team wants to make commercial use of any IP generated during an i4i project, whether during the life of the project or at any time after the project has ended and is ready for commercialisation, written consent must be obtained by the DHSC and an income- or equity-based revenue share will be agreed. We may consider requests for early agreement of commercialisation terms. Consent for commercialisation/exploitation of NIHR funded research is granted on a case by case basis.
We do not wish to prevent IP from being exploited since commercialisation is usually required to enable patient benefit from the research. Likewise, we consider SME growth and leveraging further investment to be a success metric of our programme. The consent clause within our contract is there as a safeguard to ensure any future terms are fair and reflect the investment made by the UK taxpayer.
How would income/equity share work? Will the NIHR share any new IP and will it want a financial return on any new IP created during the project?
The NIHR funds a wide spectrum of health research and is keen to support the exploitation of products or treatments developed under its funded research to ensure that the benefits are not lost to UK patients and there is a return on its investment. The return on investment will depend on the nature of the funded project and the level of funding provided and will be agreed as part of the NIHR commercialisation agreement. Potential forms of return on investment include patient benefit, cost savings to the NHS, public good and commercial return in the form of a share of revenues generated through IP licensing or consultancy, taking shares in new businesses created, or seeking product or service discounts, thereby generating cost savings. IP ownership would normally lie with the Lead applicant, or in certain circumstances with a collaborating party. The funder will not own any IP created during a i4i FAST award.