Invention for Innovation - Challenge Awards Supporting Information for Applicants
Section 1: Introduction
This document contains information on the scope, eligibility criteria and requirements of the NIHR Invention for Innovation (i4i) Challenge Awards.
Further information is available in the Finance Guidance.
The NIHR i4i programme is a translational funding scheme which advances healthcare technologies and interventions for increased patient benefit in areas of existing or emerging clinical need.
The i4i programme traditionally addresses the Translational Gap 1 (T1) identified by the Cooksey Report in 2006, translating ideas from basic research into the development of new products and approaches for the treatment of disease and illness. This Call on Real World Implementation is intended to address the second translational gap (T2), implementing new products and approaches into clinical practice.
The NIHR i4i Challenge Awards Call 12 is inviting applications for the assessment of medical devices, digital products including artificial intelligence (AI) technologies for medical purposes, and in vitro diagnostic innovations in real world healthcare settings. The aim is to shorten the gap between the evidence usually delivered by traditional safety/efficacy clinical trials typically required for a technology recently placed on the market, and the evidence which is required by commissioners and regulators to be able to make purchasing or other recommendations/decisions. At the same time, this will de-risk the product for follow-on investment.
Despite a more favourable investment landscape, there remains significant risk and therefore limited appetite to invest in SMEs scaling up to bring their products to the NHS market. Implementation of innovations in the NHS comes in response to a clinical need, and occurs with evidence of cost saving and/or improved outcomes compared to the standard of care, i.e. following careful evaluation of the clinical pathway that may be disrupted by the new intervention.
This call supports CE/UKCA marked as well as ‘nearly’ CE/UKCA marked products (i.e. medical devices & AI, and in vitro diagnostics). Nearly CE marked products will be considered where evidence can be shown that the technical documentation has been submitted for Notified Body assessment, and whereby all of the mandatory testing has been completed. For self-assessed products (Class I & Class A) we expect a CE mark to have been obtained. Please note that Stage 1 applications should include written confirmation of the above CE/UKCA marking status (i.e. "obtained" or "under Notified Body assessment"). At Stage 2, applications should supply evidence of the CE/UKCA marking status (e.g. the relevant CE certificate or a letter from the Notified Body assessor). For further information on the regulatory conditions and the upcoming UKCA marking requirements please visit our Scope webpage.
Digital health technologies that are not regulated as medical devices but are patient-focussed and are going to be integrated into the NHS will also be eligible, as long as reasonable proof of safety and efficacy is provided. We encourage such technologies to have obtained a relevant professional body endorsement from organisations such as ORCHA, NHS Apps Library, or have obtained NICE Advice (e.g. Medtech Innovation Briefings).
The i4i Programme will fund the generation of clinical evidence required for the implementation of technological innovations in the healthcare pathway, based on their use in a real world context. In other words, the testing would be carried out as if the innovation was being used in service. This might include feasibility or effectiveness studies carried out in real world settings (e.g. different types of hospitals (district general, teaching), GP practices, community care services, etc), that employ pragmatic study designs such as pathway and sustainability evaluations, qualitative assessments of the clinical burden (e.g. will the nurse need an additional 20 min in the clinical rounds in order to use the technology?) and assessments of broader downstream effects (e.g. is the technology more acceptable, less burdensome to patients with progressed usage?), etc.
Projects may last up to 3 years but could be considerably shorter, or if a strong case is made, may last up to 5 years (for example if extended patient follow-up is required to demonstrate improved outcomes). Companies and NHS organisations may receive up to 100% of the requested funding, with no requirement for matched funding for commercial organisations. Higher Education Institutions are entitled to up to 80% of the Full Economic Cost (please refer to the Finance guidance for more details).
The expected output of the i4i Challenge Awards is a technology or intervention validated in real world settings, potentially ready to apply for further (usually private) funding to scale up, or to approach commissioners or NICE for formal evaluation. A relevant technology appraisal checklist can be found in the NASSS framework developed by Prof Trisha Greenhalgh.
The recently published NHS MedTech Funding Mandate policy came into effect on 1 April 2021 to overcome the financial barriers to adopting medical devices, diagnostics and digital products in the NHS. It sets out new funding mandate criteria including technologies supported through NICE guidance or the ITT/ITP scheme, as well as technologies that may not be supported in such ways but which can demonstrate an NHS net saving across a three-year period (in addition to all other MedTech clinical and regulatory requirements). Please note that this i4i funding is intended to support the development of real world evidence that could potentially inform commissioners and potentially support the technology’s inclusion into the NHS Funding Mandate, but will not provide guarantee of successful commissioning in the NHS or inclusion in the NHS Funding Mandate and national guidelines. The objectives of the i4i Challenge Awards are to:
- Accelerate the development and uptake of innovative products, technologies and interventions for the benefit of patients in the NHS.
- Encourage the use of efficient methodologies for faster but still robust evaluation.
- Support collaborative projects led by England-based organisations targeting unmet healthcare needs.
- Provide translational funding for implementation research on technologies which have demonstrated safety and efficacy, and have a clear pathway towards clinical adoption and commercialisation.
- Encourage engagement with a Local Authority, Sustainable Transformation Partnership or Integrated Care System, as appropriate, for the assessment of the product in the health or care setting, ideally involving both procurement and commissioning expertise.
- Assess the clinical utility and health economic gains of transformative technologies, and generate meaningful evidence to support the decisions of NHS commissioners for effective deployment of the product.
- De-risk projects and make them attractive to follow-on funders, investors and buyers, in particular NHS commissioners and national guidance bodies.
- Medical devices and in vitro diagnostics should have a CE/UKCA mark at the time of application.
- Nearly CE marked medical devices and IVDs are eligible provided that the technical documentation has been submitted for Notified Body assessment and all mandatory testing has been completed.
- Non-regulated digital technologies will need to have a potential application as products in the NHS, and reasonable proof of safety and efficacy should be provided in the application. These technologies must reflect the characteristics of the Evidence Tier 3 described in the ‘Evidence standards framework for digital health technologies’ from NICE.
- All digital technologies should comply with the ‘Code of conduct for data-driven health and care technology’ and the NHSX Digital Technology Assessment Criteria (DTAC).
- A minimum of two organisations must be involved from a Small Medium Enterprise (SME), an NHS Service Provider (e.g. Trusts, community care providers, and tertiary care centres) or a Higher Education Institution (HEI), and the proposal must be led by or include at least one collaborator from an NHS Service Provider.
- Lead applicants must be based in England.
- Proposals must describe evaluations of technologies in healthcare settings. Evaluations must address an existing clinical problem and must be designed to inform decisions around its adoption.
- Proposals must demonstrate that early engagement to identify stakeholders for the project has occurred, and that the product has provisional end user interest (e.g. NICE, CCGs/ICSs, etc.). A delayed contract start date can be implemented to support formal project collaborations and improve the likelihood of successful innovation management.
- Teams are expected to demonstrate appropriate skills for the delivery of the project, such as clinical and methodological approaches, an understanding of implementation science, health economics, regulatory requirements, project management, information governance and data management.
- Work packages must not include animal studies. If animal studies are required as part of the project, we expect applicants to seek parallel funding to cover such studies, details of which should be provided in the application form.
Applicants might want to consider including the following in their proposals:
- Patient input in the design of the trial and the delivery of the intervention.
- Rigorous competitor analysis.
- A strong health economic case for the clinical utility of the product.
- An understanding of the pathway that will be disrupted by the product.
- Implementation and sustainability strategy.
- Plans for information governance.
- A realistic risk-mitigation strategy.
- Plans for stakeholder management.
- Plans for adoption into the NHS or other care systems.
Project focusing on one of the areas described in the NHS England long term plan will be prioritised.
What we fund
This funding supports research and development activities associated with the implementation of transformative technologies in healthcare settings.
Supported activities include:
- Activities associated with the design and delivery of evaluations for innovations in healthcare settings. This includes any trial methodology aimed at demonstrating the real world clinical utility of the product. The following innovations are eligible:
- Medical devices and in vitro diagnostics as defined by the relevant EU Directives effective through the UK Medical Devices Regulations 2002.
- Digital health technologies that fall under Tier 3 of the NICE Evidence Framework for Digital Health Technologies, and that are focused on patient outcomes and intended for ultimate NHS use. Evidence that the NHSX Digital Technology Assessment Criteria (DTAC) has been considered should be demonstrated in your proposal.
- Artificial Intelligence (AI) technologies including Augmented or Ambient Intelligence, applied in areas of health and social care including health promotion and prevention, diagnosis and treatment. Please note that such AI technologies will classify as Medical Devices.
- Collection of effectiveness data if this is part of a clinical utility study.
- Health economic analysis.
- Work around market analysis and development of a business case for adoption.
- Project management and stakeholder engagement activities.
- Activities associated with data analysis, management and governance.
- Small changes to the technology that might be needed for its optimisation during the lifetime of the project, e.g. any adaptations deemed required for end user acceptance as part of this evaluation but not requiring any further regulatory approvals.
- Training associated with the implementation of the new technology, including the development of training resources, usage guidelines and other materials.
- Implementation research costs, including design of implementation strategy and management of studies associated with this, clinical pathway analysis, sustainability evaluation and data analysis.
- Activities associated with the dissemination of outputs.
We expect projects to describe a combination of the activities above, rather than focus on a single aspect.
The i4i challenge award will not fund:
- NHS support costs and excess treatment costs. Please refer to the AcoRD guidance for more information.
- Scale up manufacture of the devices that will be needed to carry out the project. Applicants must develop a plan for managing possible costs associated with these, and will have to describe it if invited to submit a stage 2 application.
- Implementation costs other than those associated with research, including some of the costs incurred by the healthcare system in order to put in place the technology.
- Potential major work around technology redesign (e.g. prototype optimisation and further CE marking activities) arising from the clinical evaluation undertaken with this award.
- Trials aimed solely at determining efficacy of a product.
- Technologies falling in the Evidence Tier 1 and 2 categories described in the ‘Evidence standards framework for digital health technologies’ from NICE, such as wellness and health-tracking apps.
- Any additional work packages related to early stage or basic research.
- Evaluations of fully developed products or interventions, which have already been adopted within another NHS organisation or have a history of NHS use.
- Products to be used only in hospital administration, infrastructure and other related software.
- Professional training, including fees for PhD study.
- Development of innovation or knowledge networks and healthcare technology cooperatives which aim to accelerate the development of innovative technology products.
The lead organisation must be based in England and may be any of the types of eligible organisation listed below. Overseas collaborators are permitted but will not be eligible to receive any funding. Their role must be clearly described in the application. The following types of organisations are eligible for funding:
- SMEs (including start-up or ‘spin-out’ companies).
- NHS service providers (including Trusts, community care providers, and tertiary care centres).
- Universities, research institutes and not-for-profit organisations.
For projects to be eligible they must include a collaboration of at least two organisations, one of which must be an NHS service provider that will act as the site for the real world evaluation. For example, applications which involve partnerships between a university and its associated NHS Trust, or an SME and an NHS service provider, are considered eligible collaborations.
It is possible that a UK organisation outside England can request funding as a co-applicant, if an appropriate case is made. We would expect the application to make a strong case that the chosen co-applicant represents the organisation best placed to provide input to the planned research.
Specialist services or expertise may be brought into the team through consultancy or sub-contract arrangements, however, appropriate justification must be provided. Sub-contractors may be based outside of England.
The day-to-day running of your project should be handled through a project manager. While it is acceptable for the lead applicant to act as the project manager, for larger consortia in particular we would expect you to employ a dedicated project manager on a part-time basis.
It is expected that project teams encompass all relevant expertise required for the delivery of this project, and include clinical design and delivery, implementation science, health economics and business analysis. Stakeholder engagement, project management, data governance and regulatory competence are also a team expertise requisites.
The involvement of SMEs and/or early-stage companies in applications is particularly welcome. Large companies may be involved, but will not be in receipt of any of the i4i funds.
For all collaborations where a partner is providing in-kind contributions, the exact nature of the commitment of each partner must be clearly detailed.
Section 2: Application Process
The i4i programme operates on a two-stage application process.
Stage 1 Applications
Refer to the terms and conditions under which the award will be made prior to applying for funding. These terms are set out in the NIHR standard contract and are broadly non-negotiable. The contract will be concluded between the lead organisation and the Department of Health and Social Care, which will be managed by the NIHR Central Commissioning Facility.
Stage 1 applications should be submitted on the RMS before 1pm on the advertised closing date.
Assessment of Stage 1 applications is made by an expert Selection Committee, composed of academic, clinical and commercial expertise. Applications are scored against the i4i Challenge Awards assessment criteria.
Stage 1 applications will be shortlisted and successful applicants will be invited to prepare and submit a Stage 2 application form. Details of the Stage 2 application process will be provided at that time.
Full applications and interviews
All invited Stage 2 applications are subject to independent peer review. Applicants will see the anonymised peer reviewers’ comments and will have the opportunity to respond in writing. The application form, peer reviews, presentation and the applicant’s rebuttals are all taken into consideration by the Selection Committee in reaching their funding decision.
Stage 2 applications should be submitted on the RMS before 1pm on the advertised closing date.
All Stage 2 applicants must present their project proposal to the Selection Committee at a Selection Committee meeting. The interview takes the form of a short presentation followed by a question and answer session.
Applications are treated as confidential and all steps are taken to ensure confidentiality is maintained. In line with Department of Health and Social Care policy, i4i will publish summary minutes of Selection Committee meetings. Please refer to our Confidentiality Guidance for further details.
Post award process
Once your application has been recommended for funding, we will provide feedback as agreed with the Selection Committee. Successful applicants are expected to start their project within four months of the funding notification, subject to satisfactory completion of due diligence and a fully signed contract. As mentioned in Section 1, a delayed contract start date can be negotiated to support the establishment of formal project collaborations, as this is key for the likelihood of successful innovation management. The Department of Health and Social Care reserves the right to withdraw the funding offer at any time after six months of the funding notification.
The due diligence process starts after submission of Stage 2 applications. Its purpose is to highlight any potential areas of weakness or concern within the project, allowing the Selection Committee to make recommendations how to address these weaknesses and to identify the level of project monitoring that will be required. Projects recommended for funding will have to satisfy all conditions imposed by the Selection Committee and the i4i Secretariat before the funding agreement can be put in place.
In addition to any changes to the work plan that may be requested by the Selection Committee, further information may be requested on project finances, project management, intellectual property and commercialisation. Funded applicants may be required to engage with an independent advisor for the revision of the project plan or any other project elements.
Section 3: Assessment Criteria
Stage 1 and Stage 2 applications will be assessed against the following criteria:
- Clinical need, health economic case and impact on the NHS and patients
- Level of innovation
- Case for evaluation study based on proof of safety and efficacy, including evidence from the literature
- Quality of the project plan, including technical and research content, evaluation methodology and risk mitigation strategy
- Strength of the project team and management arrangements
- Intellectual property (IP), plan for adoption and commercialisation strategy
- Value for money
- End user engagement and patient and public involvement
Clinical need, health economic case and impact on the NHS and patients
The proposed research must be highly relevant to the healthcare priorities of the NHS and must respond to an existing clinical need. The clinical utility of the project must be clearly articulated. A clear case has to be made for how the proposed device, diagnostic or technology might influence clinical practice. This should include a strong health economic case that takes into account the clinical pathway that will be disrupted, highlighting advantages over the current gold standard and any constraints in potential adoption. The proposal should explain how the ultimate output of the project is the generation of evidence to support the preparation for potential adoption of the new technology.
Level of innovation
Applicants must demonstrate how the proposed device, technology or intervention presents a significant level of innovation, providing an advance over currently commercially available alternatives. The proposal will need to articulate how the project will generate relevant data to inform their decisions.
Case for evaluation study based on proof of safety and efficacy, including evidence from the literature
Applicants will need to provide evidence of safety and efficacy of the technology to support the case for implementation. Applicants could consider providing details of key data generated in prior studies that support the project in the appendix of the application form at stage 2. Any claims or assertions made about the technology in the Case for Support section, including the plain English summary, must have references provided.
Quality of the project plan, including technical and research content, evaluation methodology and risk mitigation strategy
The proposed project must be focused on implementation evaluation in healthcare settings, and the challenges associated with this should be clearly discussed. Project aims and objectives must be realistic in terms of time and resources requested.
It is vital for the proposal to provide as much detail as possible on the following areas:
- Implementation research plan. The project design should be targeted to the context where it will be delivered, taking into account appropriate patient cohorts, stakeholders, end users and the clinical pathway that will be disrupted. Studies can focus on a single healthcare provider, but it would be ideal if impact on a wider system could be demonstrated (e.g. at an Integrated Care System level).
- Clinical and technical evaluation. It is expected that proposals describe ‘real world testing methods’ rather than a purely academic approach, and patients should have an input from the outset. For example, rigorous but adaptable and pragmatic trial methodologies will be more suitable. The study should demonstrate the clinical utility of the intervention and should assess the technology against the appropriate comparator(s). The evaluation should be designed taking into account how the technology fits in the clinical pathway. Plans for data and information governance should be in place.
- Stakeholder engagement.The proposal should describe a stakeholder engagement plan, including end users (regulatory bodies, commissioners, etc.), collaborators and possible contributors (e.g. NIHR Infrastructure, AHSNs, policy makers, etc.), detailing how they will input in strategic decisions.
- Evaluation of the intervention. A strategy for the evaluation of the intervention must be outlined, including a clear set of outcome measures that will define the success of the project.
- Risk assessment. The project plan must adequately address aims and objectives, include a realistic assessment of the main challenges, and propose appropriate steps for the mitigation of risks. This should include main technical and clinical barriers, management of stakeholders, and issues with potential adoption. A risk register should be maintained and updated during the timeline of the research. If a favourable ethical opinion is required to carry out the project, evidence for approval must be provided before project start, or before start of the respective work package. If ethical approval is only required in later stages of the project, it will be a distinct deliverable of the project and part of a funding stage gate. Similarly, if collaboration agreements are not finalised ahead of the start of the project, conclusions of these agreements will be included in the contract as a funding stage gate.
All projects must adhere to the research governance framework for health and social care. Projects involving clinical trials should follow the MRC guidelines for good clinical practice in clinical trials. Researchers designing or undertaking clinical trials are also encouraged to consult the Clinical Trials Toolkit. This NIHR resource is an innovative website designed to help researchers navigate through the complex landscape of setting up and managing clinical trials in line with regulatory requirements. Although the Clinical Trials Toolkit is primarily aimed at publicly funded Clinical Trials of Investigational Medicinal Products, it will also provide researchers and R&D staff working on trials in other areas with useful information and guidance.
Strength of the project team and management arrangements
Arrangements for managing the project must be adequate, and roles of team members must be clearly described. Project teams are expected to have included expertise in all areas relevant to support the proposed device, technology or intervention towards implementation. Any relevant previous experience should be included. It is possible to request resources for external expertise, e.g. consultants for health economics or regulatory development. Teams must appoint a Project Manager to coordinate and oversee project activities and should consider establishing an ‘innovation management team’ to coordinate all activities associated with project delivery, risk mitigation and stakeholder engagement.
Intellectual property (IP), plan for adoption and commercialisation strategy
All background and any potential foreground IP arising from the project must be described in the application. An initial freedom to operate opinion must be provided, referencing any third parties’ rights which may affect the implementation of your device or technology. A strategy should be put forward as to how third party rights will be managed to allow for further development, implementation and commercial exploitation.
IP arrangements between collaboration partners, and with consultancies and sub-contractors must be regulated by appropriate agreements. The Lambert Toolkit provides model agreements for collaborations between universities and companies.
The proposal should present a strategy for adoption of the technology into the NHS and other healthcare systems. This should include a plan for the exploitation of the data produced during the project, the identification of the key stakeholders to engage, and potential sources for onward investment. In addition, market opportunities, both domestic and global, and the expected impact of the proposed technology or intervention can be explored.
Value for money
All requested costs must be sufficiently justified and essential for the proposed work; however, it is expected that all applications aim at achieving real clinical impact, so the requested amount should allow for effective evaluation of the device, technology or intervention. Taking into account the expected benefits of the proposed work and the level of funding requested, the proposal must demonstrate value for money. Any funds requested for NHS support and treatment costs must be appropriate and justified.
End user engagement and patient and public involvement (PPI)
Evidence must be presented of early engagement of end users (e.g. NICE, clinical commissioning groups, etc.) and their provisional interest in the product.
The NIHR expects active involvement of patients and the public in the projects it supports. It is anticipated that most i4i projects will have a significant PPI component, which must be clearly and fully described. Applicants should identify the relevant patient/user group(s) for their application and engage with those groups at an early stage. For this funding stream it is highly encouraged to seek patient and public contribution early on in the project, possibly at the design stage. To make the contents of your application and the implications of your project clear to members of the public, but also commissioning boards and reviewers, a plain English summary is required (see Plain English summary for further details). Further guidance and PPI resources can be found under Patient and Public Involvement.
Section 4: Privacy and Data Protection
The CCF Research Management System (RMS) is hosted by Pulsant. The Data Controller for the website is the Department of Health and Social Care (DHSC). The Data Processor is the CCF, based at LGC.
The purpose for which personal information is collected through the RMS is to deliver the work of the CCF in relation to the operation of research programmes, faculty and infrastructure workstreams. Data will not be used for any other purpose without the consent of the supplier.
Use of the registration and application facility on the CCF RMS is entirely voluntary and the personal information stored will be used solely by the CCF, its subcontractors and partners in order to respond to your enquiries and send information relevant to its work.
To prevent unauthorised access, maintain data accuracy, and ensure the correct use of information, the CCF has put in place appropriate physical, electronic, and managerial procedures to safeguard and secure the information it collects online. The information you provide will be held securely and in accordance with the Data Protection Act 1998. The Department of Health and Social Care, National Institute for Health Research (DHSC NIHR) is the Data Controller. Your personal details provided on registration will not be disclosed to third parties. Details that are provided on research application forms must necessarily be shared in confidence with third party individuals involved in making funding decisions.
Your information may also be shared with other DHSC NIHR bodies for the purposes of statistical analysis and other DHSC NIHR management purposes, including targeted communications with selected groups of researchers. In addition, information collected is used by the CCF, its subcontractors and partner organisations:
- To administer the grant application process
- To identify peer reviewers for grant applications
- To notify users about funding opportunities by email
- To notify relevant users about application deadlines by email
- To notify users of any issues of service interruptions, holiday closures and other situations affecting the operation of the CCF RMS.
Section 5: Equality and Diversity Monitoring Information
NIHR is committed to promoting equality, diversity and inclusion in research and asks applicants to provide Equality and Diversity Monitoring Information (age, sex, ethnicity and race, and disability). By answering these Equality and Diversity Monitoring Information questions, you will help us to better understand the different groups of people that apply to us for funding and their experiences of the funding process – particularly the groups protected by UK equality legislation. Although it is mandatory to answer these questions, it is possible to select “prefer not to say” as a response. However, the more information you provide, the more effective our monitoring will be. This information will not be used to make decisions about funding.
Section 6: Research Design Service
Applicants may wish to seek advice on the content of an application via their regional Research Design Service (RDS). It is advisable to make contact as early as possible to allow sufficient time for discussion and a considered response.
Section 7: NIHR Medtech and In vitro diagnostics Co-operatives (MICs)
Applicants may wish to seek support from a relevant NIHR Medtech and In vitro diagnostics Co-operative (MIC) which build expertise and capacity in the NHS to enable evidence gathering for new medical devices and in vitro diagnostic (IVD) tests.
Section 8: Clinical Trials Unit (CTU) Support
CTUs are regarded as an important component of any trial application and can advise and participate throughout the process from initial idea development and design through to project delivery and reporting. However they may not be essential for all types of clinical research studies. If you feel this is the case please justify the reasons in your application in the appropriate section.
If you are looking for a CTU to collaborate with in your application, then the following sources can provide more help:
CTU Support Funding provides information on units receiving funding from the NIHR to collaborate on research applications to NIHR programmes and funded projects.
The UKCRC CTU Network provides a searchable information resource on all registered units in the UK, and lists key interest areas and contact information.
Section 9: Resubmission Policy
Although we do not prohibit the submission of applications which were submitted unsuccessfully in previous application rounds, applicants should recognise that the original applications were judged to be uncompetitive in that round, or significantly flawed, and are therefore likely to need substantive modification to have a realistic chance of being funded in future competitions. Previously unsuccessful applicants should therefore pay particularly close attention to any specific feedback provided prior to re-applying.
Section 10: Public Involvement
Further information and resources for researchers about involving patients and the public in research can be found on the make a strong application webpage. This includes a detailed definition of patient and public involvement in research, briefing notes for researchers on how to involve patients and the public and payment guidance.
The NIHR Research Design Service provides 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 11: Ethics / Regulatory Approvals
Guidance on the application process for ethical and other approvals can be found on the HRA website. Please note that if your study is led from England and involves the NHS in England you should apply for HRA approval.
If you are using patient information from an existing database, you should check whether the patients have given their consent for their data to be included in that database for research purposes, or if not whether the database is exempt under Section 251 of the NHS Act 2006. Where exemptions are not already in place, approval to use confidential patient information without consent must be requested from the HRA who make decisions with advice from the Confidentiality Advisory Group. (CAG).
NOTE: The programme is interested in taking advantage of the growing utility of routine data (such as HES, GP records etc.), and would like investigators, where appropriate, to ask study participants to consent to long term follow up (e.g. beyond the outcomes to be collected in the funded trial) using routinely collected data, and appropriate linkage to allow this data to be best used.
Section 12: Carbon Reduction Guidelines
Researchers applying for NIHR funding are asked to consider the carbon footprint of their research and take steps to reduce carbon emissions where appropriate. Advice on how to do this can be obtained from the Carbon Reduction Guidelines
Section 13: Transparency Agenda
In line with the government’s transparency agenda, any contract resulting from this tender
may be published in its entirety to the general public. Further information can be found at transparency agenda.
Section 14: Guidance on Completing the Application Form
To submit an application, you must complete all the relevant sections of the online form available within the Central Commissioning Facility Research Management System (CCF RMS).
The ‘System Help’ document found on the CCF RMS’s web pages provides extensive step by step instructions on how to make use of the CCF RMS.
Only registered users of the CCF RMS can apply. Applicants new to using the CCF RMS should register as a new user. Once logged into your account the RMS home page is the starting point to create applications, access co-applications and to update contact information and professional details.
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 RMS home page. Lead and co-applicant contact information and CV details are integrated by the RMS 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. 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. The RMS 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 RMS 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 RMS 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. 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 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 RMS 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.
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.
Section 15: Post Award Monitoring
Progress and financial reports
i4i will oversee the management and progress of funded projects based on the deliverables and milestones agreed in the contract. An i4i programme manager will be assigned to your project and will be your main point of contact, offering advice and guidance to assist your team with maximising the outcome of your project. Quarterly progress reports, email communication, phone calls and site visits will enable the programme manager to evaluate progress and the achievement of deliverables and milestones, as well as signpost the appropriate services when needed, enable connections with other parts of the NIHR and provide general advice and support.
As payments will normally be made quarterly in arrears (at the end of March, June, September and December), you will also be required to provide quarterly expenditure reports and an annual statement of expenditure. Universities and NHS organisations will be paid as agreed in the payment schedule. Commercial organisations are required to issue invoices at the end of each quarter; any deviation from the scheduled payment in the contract must be thoroughly explained. Any funding not spent at the end of each financial year may be recovered by the Department of Health and Social Care or set off against any future payments. In such situations, a new payment schedule will be issued.
When a scheduled payment is linked to a funding stage gate, the project team must clearly demonstrate that the contractually defined milestone has been achieved before any payment will be released. If a milestone is not achieved, payments may be withheld until the milestone has been achieved or an appropriate contingency plan has been agreed.
Return on investment
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, such as reduced morbidity or mortality, and improvements in quality of life
- Cost savings, resulting from innovative practice methods developed within the public health and social care systems funded by the NIHR
- 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
- Public good, such as a demonstration of the impact of NIHR funding on the health and prosperity of the nation.
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 after the project has ended and is ready for commercialisation, written consent must be obtained by the Department of Health and Social Care and an income- or equity-based revenue share will be agreed. We may consider requests for early agreement of commercialisation terms. The terms as set out in the NIHR commercialisation agreement will form the basis for negotiation.