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Invention for Innovation Funding At the Speed of Translation pilot - Frequently asked questions

Published

04 April 2022

Version

1.0 - April 2022

Contents

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 FAST pilot is launched to gauge the level of interest in this type of funding call and can close at any time subject to budget and evaluation requirements. 

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 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 innovations at any stage of development, provided there is demonstrated proof of concept.

Eligibility

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 can not re-apply to the FAST pilot whether they were successful or not. 

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. 

What activities could be funded by FAST?

The i4i FAST pilot would consider funding for a range of activities, provided the ultimate innovation to be developed is within the remit of the i4i Programme. Funding is provided for innovators to answer a specific question and FAST should not be used to conduct a small scale project. Please see the guidance for applicants for the full.

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, whether this is through its own in-house staff, collaborators, or subcontractors. 

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 and are not non-eligible costs covered in the guidance for applicants

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 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 Schedule D in our example of the NIHR standard contract for commercial organisations. Please note, contractors are also required to seek NIHR's consent prior to commercialisation of any product that arise from the project (Please see section on Exploitation of Intellectual Property).

What is required for the SoECAT form section of the application?

Please note this is exclusively applicable for i4i FAST Award applications due to the fast review cycle; no other NIHR funding programmes are affected. 

A SoECAT is required by NIHR and NIHR non-commercial partner research funders where the call relates to studies that may involve participants under an NHS or Health and Social Care duty of care. A SoECAT should be completed for the Research Cost funding application for any non-commercial study eligible for NHS support and treatment costs. SoECAT is not used for commercial contract research studies. T

Exclusively for the i4i FAST scheme,  applicants can upload a SoECAT form in draft with pending AcoRD Specialist sign-off if this cannot be obtained quickly. This is under the premise that the SoECAT must be authorised and signed off within the 4 week due diligence period before project start, if awarded funding. 

If you need support from an AcoRD Specialist in your region on how to correctly identify and attribute relevant activities and to authorise the completed SoECAT, please contact your local CRN.

Do I need to submit a SoECAT if I don’t have any associated NHS treatment and support costs?

If the applicant determines there are no associated NHS support and treatment costs with the project, then only the front page (study information tab) of the SoECAT needs to be uploaded and submitted as part of the application.The SoECAT will still need to be authorised and signed off by an AcoRD Specialist even where there are no costs.

However, in order to accommodate a fast review cycle, for the i4i FAST scheme exclusively, applicants can upload a SoECAT form in draft with pending AcoRD Specialist sign-off if this cannot be obtained quickly. This is under the premise that the SoECAT must be authorised and signed off within the 4 week due diligence period before project start, if awarded funding. 

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, unless otherwise agreed with a NIHR Programme Manager. 

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 Department of Health 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 funded i4i FAST award.