This document outlines answers to questions frequently asked by applicants to the Invention for Innovation (i4i) NIHR & OLS Cancer Mission: Early Cancer Diagnosis Clinical Validation and Evaluation Call. More information is available in our OLS- Cancer Mission Guidance for Applicants, and in our OLS- Cancer Mission Supporting Information for Applicants.
- Last updated on 18 October 2023
- Contact us on ols-cancer-mission@nihr.ac.uk
General
Q: Is there any weighting assigned to the assessment criteria listed in the i4i NIHR & OLS funding call supporting information?
The application is assessed in its entirety against the eight assessment criteria in the supporting information for applicants; there is no specific weighting allocated to each criterion.
Q: Can one organisation submit two different applications to the same NIHR & OLS funding call ?
Yes, but you would have to clearly indicate the differences, and where applicable, potential synergies.
Q: The application form indicates that there is potential for Joint Lead Applicants. Please clarify the implications of this and under what circumstances it would be acceptable.
An application might include Joint Lead Applicants for a number of reasons and is project dependent. Common examples are (but not limited to): if the intended Lead does not have experience of leading large projects; or if there are two co-applicants equally involved in the project from two different organisations. Justification for Joint-Lead applicants must be given. Please note only one organisation (the lead organisation) will be party to the funding contract with DHSC.
Q: Can an application for this call be submitted whilst waiting for an outcome from another award?
Yes, but this must be explained in the application form. If the project is the same or very similar, applicants will not be awarded funding for both projects.
Q: Can a commercial SME be a joint lead?
Yes, provided as the joint lead, the SME is based in the United Kingdom. An explanation should be provided to justify why joint leads are required to lead the proposed research and how this brings value to the application. Please note we do not expect foreground IP generated from the research to be jointly owned.
Q: Can the SME be a new spin-out startup from the NHS organisation or university?
Yes, spin-outs and start-ups can be the lead organisation or collaborating organisation at the start of the project. However, do ensure that individuals are not costed across multiple organisations (e.g. PI time costed at university and also SME).
Q: Can we request funding to support work at NIHR MedTech and In Vitro Diagnostics Co-operatives (MICs), i.e. for PPIE activities? Similarly, can a MIC be a partner and lead that aspect of a proposal?
Yes, funding can be requested to support work planned to be delivered by MICs. You can list a MIC as your collaborating organisation and explain what aspect of your proposal is supported by them. There are 11 NIHR MICs that work in partnership with innovators to help them successfully translate innovative ideas into the clinical setting, and cover a broad range of expertise including, PPI, patient care pathway analysis, user testing and human factors and regulatory advice. See the NIHR MICs website for more details. It is encouraged that engagement with NIHR support services occurs as early as possible in developing the project.
Q: How many collaborators or partners can be involved in the project? And how would the budget be separated between them? Under what criteria should we choose the lead applicant?
Up to 7 collaborators can be involved in the project but you would need to ensure that effective control of the project can be maintained. We expect a single collaboration agreement with all the collaborators to ensure this, particularly to protect what happens to intellectual property and the participants' freedom to operate. The budget will be attributed to each collaborator based on the lead applicant cost allocation based on the proposed work.
Q: How long after the outcome of the submitted application is announced is the funding available for use?
The earliest possible date for projects to start is July 1st 2024 providing the due diligence and contracting processes have been completed. The length of time required to carry out the due diligence process can vary based on the project, but should not exceed four months from the date of receipt of the outcome letter.
Q: Do contracts (for example a data sharing agreement with a partner NHS organisation) need to be in place before an application is made or can this be completed when/if the funding is awarded?
There is no requirement for any contracts to be in place prior to applying for this call. We would expect initial discussions with collaborating partners and data access relevant to the project to have started and to reflect their commitment in the application. We request copies of the draft collaboration agreement and any other agreements relevant to the project as part of our due diligence process. Where prior agreements are already in place with partners, this should be explained in the proposal and provided during due diligence.
Q: Are i4i Applications confidential?
i4i applications are confidential. More information can be found in our document Confidentiality and disclosure - a guide for applicants, reviewers and commissioning committees. If funded, the Plain English Summary, Chief Investigator/Co Investigator(s) names, award amount, start date and end date will be published on the NIHR funding and awards page.
Project specific
Q: Is product development allowed in this call?
Only a minimal amount of product development is allowed in this call. Applications should demonstrate that the proposed innovation has been validated in the lab and there is a prototype ready for in human testing.
Q: Are real world implementation studies allowed in this call?
No, this call will only fund clinical validation/evaluation activities that are precedent to real world implementation studies and that focus on the market preparation of the innovations (TRL 4 - 9), rather than the post-launch evaluation. Funding will be deployed to facilitate the generation of evidence on safety, test performance characteristics, clinical efficacy and/or effectiveness that can support regulatory approvals requirements and subsequent clinical implementation or implementation research, which will be undertaken outside this call. There are other funding initiatives that support evidence gaps for that stage of development (e.g., the NHS Cancer Programme Innovation Open Calls), and we encourage applicants to refer to those to fund real world implementation studies.
Q: My product is already on the market for a different clinical application. Can I apply to this call to generate evidence for early cancer detection and diagnosis?
Yes, this call provides an opportunity for innovations used for different cancer types or therapeutic areas to generate evidence in a new cancer priority. Please make sure that the project focuses on the clinical validation/evaluation work, as substantial technical development activities to adapt the innovation to the new pathway will not be supported.
Q: What evidence base is necessary/appropriate for validation?
Applicants should ensure that they provide enough evidence that a technology/intervention has sufficient early validation to give the Assessment Committee confidence in the proposed project. This will differ depending on the type of technology/intervention and in general it should be commensurate with the level of development of the proposed product and should justify that the study proposed in the application is the logical next step for its validation/evaluation. Applicants can submit a pre-submission engagement form with their project idea if they require clarification.
Applicants should also make sure to have sufficient statistical expertise to ensure their test shows a significant response.
Q: Are applications that target cancers that already have a screening programme in place eligible for this call?
Yes. Cancers with existing programmes are in scope and innovations aiming to compete with them or to enhance, refine or optimise them are welcome. However, applicants are encouraged to compare their innovations to the existing programme and to explain how they believe their innovation will affect them.
Q: What proof of ethical clearance is required at the application stage?
Applicants are encouraged to discuss ethical approval requirements with their local Clinical Research Network and the Health Research Authority (HRA). All necessary approvals must be sought during the course of the project or before, and this should be stated and/or planned for within the application. It is important to account for sufficient time for the required approvals to be reached in order to make the project deliverable.
Q: Can an application be for more than one activity, e.g. RCT for clinical effectiveness, CE/UKCA marking, and economic impact analysis?
Yes, as long as all the activities are directly relevant and support the development of the principal technology. In fact we expect to see varied work packages that link together for comprehensive product validation/evaluation.
Q: Is there a preference for projects targeting specific cancer sites?
No. No cancer site is preferred or excluded. We will not be allocating funds based on cancer types but the quality of the proposal.
Q: Are rare cancer subtypes eligible for this call?
Yes, rare cancer subtypes are eligible for this call and there is a strong unmet need for early detection of these cancers. However, the research proposed for these cancers needs to be carefully designed to take into account the smaller population affected and the effect this has on the recruitment and significance of the data collection and analysis.
Q: Is an innovation that has been CE marked (or equivalent) and used overseas in scope?
Yes, innovations that have gathered evidence outside of the UK and are currently planning on validating and evaluating their innovation for use in the NHS are in scope of this call. Applicants are encouraged to take into consideration the difference between the different populations targeted in each area and that they explain how they will take this into account in their project.
Q: Do you encourage early career researchers to apply with lesser track records of funding? Or are you looking to work with more established researchers?
Project team is part of our assessment criteria. We expect applicants to have the appropriate skills to ensure project success. You are welcome to apply as a lead and if you feel it is necessary to have a more established researcher in the project team they can be made co-applicant in your application.
Q: I currently don't have a collaborator on my project. Do you have advice on how to find suitable NHS or university collaborators?
Yes. Please contact our Industry team, where you will be directed to the relevant clinical collaborators for your project. In addition, you can use the AHSN Network which will support you in connecting with an appropriate partner.
Q: Is there a way that we should evidence our Tier C status if we are a digital health technology (DHT)?
Applicants must evidence that their DHT meets and satisfies the Tier C criteria as set out in the NICE Evidence Standards Framework for Digital Health Technologies and it must be evident in the proposal that the innovation falls into Tier C classification. Tier C covers DHTs for treating and diagnosing medical conditions, or guiding care choices and includes those with direct health outcomes, or that are likely to be regulated medical devices.
This call does not support DHTs that fall into either Tier A or Tier B classification, including those that help patients to manage their own health and wellness, or that intend to save costs or release staff time with no direct patient, health or care outcomes.
Finance and Intellectual Property (IP)
Q: 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.
Q: How are the funds paid out? What is the percentage of total costs budgeted usually granted on average? How are funds distributed to the Collaborators?
This call provides funding for 100% of research costs, normally paid quarterly according to a payment schedule defined at the contracting stage. For HEIs, up to 80% of Full Economic Cost will be paid, provided that TRAC methodology has been used. For applications where the contractor is an NHS body or a commercial organisation, up to 100% of costs will be paid. For more information see the i4i Finance guidance.
Payments will be made in arrears 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.
Q: Can early work conducted now, before funding is awarded, still be claimed and funded at a later date if successful, or are there restrictions on when costs are incurred i.e. this must be after the project start date?
Earlier work, prior to project commencement will not be funded and therefore should not be claimed. Project costs can only be incurred from the start date of the project.
Q: Where can I find more information on what to include as NHS support and treatment costs?
A: Local Clinical Research Networks are there to advise on NHS support and treatment costs. A summary of what these costs include can be found in the i4i finance guidance.
Q: Is there a funding limit for each project?
Funding for this call is uncapped. Typically, awards range between £0.5m-£1.5m but applications do not have to be within this range. Applicants should make sure that they justify their costs and that their project offers value for money.
Q: Are University staff costs funded, such as a PostDoc salary or time?
The appropriate amount of a PostDoc salary for their time contribution to the project is eligible. The Awards are for projects, so costs are looked at on that basis.
Q: Is there a limit to subcontracting fees for e.g. IP/FTO searches and patent filings throughout the project?
There is no limit to the amount paid to subcontractors. However, these costs need to be fully justified. Please note that one of the criteria for assessing applications is whether the project would provide good value for money and subcontracting costs may be considered as part of this.
Q: Can the cost of capital equipment be included in the grant application?
Capital equipment costing up to £5k, excluding VAT, will be considered. Costs of computers are normally restricted to a maximum of £650 each excluding VAT. For a more detailed overview please refer to the Finance Guidance.
Q: Can rental of a piece of capital equipment be included?
Rental for a piece of capital equipment can be included within your application, but the need to do so must be justified.
Q: What happens with arising IP if it is an improvement to existing IP owned by an SME partner?
Contracting organisations must disclose any encumbered background IP which is required for the purpose of the NIHR funded project. As with any NIHR funded foreground IP generated in the project, the ownership of improvement to any background IP will need to be agreed upon during the contracting stages.
Q: I am unclear about the consent clause in the standard NIHR research contract. Since there is no equity in the company, a clause potentially stopping IP being used can cause problems for SMEs, in particular for future funding as it may limit the commercial strategy. Could you please elaborate on how post project commercialisation will work?
Please refer to the NIHR Intellectual Property and Commercialisation Guidance. 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 Social Care. We may consider early consent requests if appropriate. Consent for commercialisation or exploitation of NIHR funded research is granted on a case by case basis. The consent process is to ensure exploitation is maximised to ensure patient research. 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.
Q: Could you please confirm how the income/equity share works. Will the NIHR share any new IP and will it definitely 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 project.
Q: Does the applicant need to have secured a patent before applying to this call ? How can the applicant demonstrate the IP value of his proposal?
There is no requirement for having a patent granted at the time of submission of an application. However, we are looking for strong evidence that the level of innovation in the proposed technology is high. Providing competitor analysis and clearly describing how the proposed technology stands out from any similar ones or any alternative solutions to the same problem would be taken into account. Seeking a professional consultation with a patent attorney could be an additional way of supporting the strong IP position of the project further.
Q: Can you say more about establishing Freedom to Operate? What evidence is needed for this?
The ideal evidence for clear FTO would be provided by a professional search conducted by an IP law firm. However, this is not a requirement for submitting an application for the programme and internal FTO searches are acceptable at this stage.