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Invention for Innovation - Product Development Award Supporting Information for Applicants

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Published: 21 April 2020

Version: 7.0 February 2024

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The NIHR Invention for Innovation (i4i) Programme is a translational research funding scheme aimed at the research and development of medical devices, in vitro diagnostic devices and digital health technologies addressing an existing or emerging health or social care need.

Examples of funded projects can be found on the NIHR Funding and Awards website.

We have decided to streamline our funding offer for applicants by merging the Product Development Awards and Challenge Awards into a single funding stream starting in April 2024. This means that the scope of the Product Development Awards will now cover projects ranging from preclinical and clinical product development to real-world evaluations.

Key information

Scope: Preclinical and clinical product development and development of real-world evidence for NHS or social care adoption

Entry point: Experimental proof-of-concept or laboratory-validated technology; innovations focusing on real-world evidence generation must have regulatory approval or demonstrated equivalent safety and efficacy for the intended use

Exit point: Depending on the entry point, laboratory and/or clinically validated technology or performance of technologies evaluated in a real-world setting

Applicant eligibility: HEI, SME, NHS or social care provider, not-for-profit organisation

Minimum number of co-applicants: 2

Funding level: No maximum, we are encouraging ambitious projects with the potential to make a real impact 

Project duration: Up to 36 months (where justified, for example for longitudinal studies, the duration may be up to 60 months)

Scope

The i4i Product Development Awards (PDA) support collaborative research and development projects of medical devices, in vitro diagnostic devices and high-impact patient-focused digital health technologies for use in the NHS or social care systems. PDA are researcher-led and aim to de-risk innovations, supporting early product development through to real-world evaluations, to make innovations more attractive for follow-on funding and commercial investment. The expected focus of a project funded by PDA is one or more of the following:

  • Product development required to enable technologies for clinical use or use in social care
  • Clinical development of a laboratory-validated technology
  • Real-world evaluations to accelerate the development and uptake of innovative products, which already have demonstrated safety and efficacy

The aim is to achieve benefit to patients and end users, de-risk technologies and make them attractive to follow-on funders, investors and buyers, in particular NHS commissioners and national guidance bodies.

All proposals must involve one of the following, and you are expected to state the classification of your technology very clearly in the application:

 

As a minimum, applicants must have demonstrated proof-of-concept, which is generally described as TRL3, and supporting evidence should be provided in the application. Applicants are expected to have generated experimental data and/or to have concluded a robust review of existing literature to support the case for further development and illustrate technical feasibility.

The Product Development Awards will support various activities, including the development of innovative technologies, preclinical and clinical trials, gathering evidence for regulatory approval, and conducting follow-up studies. A strong element of patient and public involvement and end user engagement is a prerequisite for PDA. 

Additionally, PDA can focus on generating evidence needed for implementing technological innovations in healthcare or social care pathways, based on their use in real-world contexts. Real-world testing might include feasibility or effectiveness studies carried out, for example, in different types of hospitals (such as district general or teaching hospitals), GP practices, local authorities or community or social care settings. These studies are expected to employ pragmatic study designs such as pathway and sustainability evaluations, qualitative assessments of the clinical burden (for example additional time needed to use the technology) and assessments of broader downstream effects (such as patient or end user acceptability).

Proposals must also set out a commercial strategy that takes into account the regulatory pathway, IP management, commercial barriers, health economics and route to market. A plan for future adoption of the technology into the NHS or social care system should be presented. Applicants should be aware of the NHS MedTech Funding Mandate policy, which came into effect in April 2021 to help overcome the financial barriers to adopting medical devices, diagnostics and digital products in the NHS, as well as other government policies as updated.

Projects may last up to 3 years. In exceptional circumstances up to 5 years may be requested, for example, if extended patient follow-up is required to demonstrate improved outcomes. SMEs 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 costs (please refer to the Finance guidance for more details).

Pre-award support

Prospective applicants are encouraged to attend i4i webinars, which are arranged throughout the year and advertised on the i4i website. If you have any queries about whether your proposal is eligible for i4i funding, please send an email with specific questions to the i4i Programme team on i4i@nihr.ac.uk.

Who we fund

Applicant eligibility

The lead organisation must be based in the UK and must be one of the eligible organisations listed below:

  • NHS and social care service providers, including Trusts, primary care and community care providers and tertiary care centres
  • Higher Education Institutions (HEI), including universities and research institutes
  • Small and Medium Enterprises (SMEs with a staff headcount no greater than 250 and an annual turnover no greater than €50 million, including start-up or spin-out companies)
  • Not-for-profit organisations, including charities and Community Interest Companies

Projects must include a collaboration of at least two organisations and may include two or more of the same organisation type. For example, proposals which involve partnerships between a university and its associated NHS Trust, or an SME and an NHS service provider, are considered eligible collaborations. If support for a clinical trial is requested, one or more of the partners must be an NHS organisation or social care service provider that will act as the site(s) for evaluation.

Specialist services or expertise may be brought into the team through consultancy or sub-contract arrangements with appropriate justification. Sub-contractors may be based outside of the UK if suitably justified.

Tips for assembling a strong team

  • Project teams must have demonstrable expertise and experience in all areas relevant to deliver the project, which may include scientific research, product development, clinical study design and delivery, implementation research, information governance and data management, patient and public involvement, project management, intellectual property management, regulatory strategy and health economics. 
  • For projects with a clinical emphasis, it is expected that project teams encompass all relevant expertise required for the design and delivery of the clinical study, such as clinical trial methodologists, statisticians, research nurses, allied health and/or social care professionals. The involvement of an accredited Clinical Trial Unit (CTU) is expected for larger clinical studies including Randomised Controlled Trials, and justification needs to be provided for studies where this is not the case. Generally, we encourage the involvement of a CTU in the design and delivery of any clinical studies. 
  • We expect the day-to-day running of projects to be handled by a project manager. While it is acceptable for the lead applicant to act as the project manager, for larger consortia in particular we strongly advise the inclusion of a dedicated project manager on a part-time basis.
  • The involvement of SMEs and/or early-stage companies in applications is particularly welcomed. If an application is led by an HEI or other organisation and an SME is participating as a collaborator, we strongly encourage you to provide sufficient details about the trajectory towards commercialisation and what role the individual organisations will play.
  • Overseas collaborators may be involved, however, their involvement must be justified and the focus must be on demonstrating ultimate patient benefit in the UK.
  • Large industry collaborators may also be involved but they will not be eligible to receive any funding, and their role in the project must be clearly described.
  • Any in-kind contributions must be clearly detailed.

What we fund

Our funding supports a range of activities from those associated with the research and development to activities associated with the implementation of transformative technologies in health and care settings. We expect projects to involve a combination of the activities below rather than focusing on a single aspect.

The following activities may be supported by an i4i Product Development Award:

  • Prototype development and manufacturing, including engineering, performance testing, design verification and validation, packaging and sterilisation
  • Exploratory first-in-human and pilot clinical studies, including iterative product development as well as the establishment of safety, providing an understanding of device performance and effectiveness, defining its intended use and informing the design of any further studies
  • Feasibility studies for technologies developed in a sector other than health
  • Pivotal clinical studies for the evaluation of safety and efficacy of a device in its intended use
  • Design and delivery of evaluations for innovations in health or social care settings, including methodology aimed at demonstrating the utility of a product
  • Clinical utility studies to explore usability, tolerability and user acceptance
  • Collection of effectiveness data if it is part of a clinical utility study
  • Implementation research costs, including design of implementation strategy and management of studies associated with this, clinical pathway analysis, sustainability evaluation and data analysis
  • Software/module design, API integration, data management and architecture
  • CE/UKCA marking and other regulatory requirements, including work towards QMS development and the Clinical Evaluation Report 
  • Patient and public involvement and end user engagement
  • Health economic analysis, such as a budget impact or market analysis to build or improve the economic case for early stage products, a cost effectiveness study or model for later stage products, using methodology to generate evidence required to meet national standards, e.g. the NICE Evidence Standards Framework for Digital Health Technologies
  • Intellectual property protection, including the filing of new patent applications for IP developed within the duration of the project
  • Competitive landscape and market analysis, development of plans for commercialisation, development of a business case for adoption
  • Project management and stakeholder engagement activities
  • Activities associated with data analysis, management and governance
  • Training associated with the implementation of new technology, including the development of training resources, usage guidelines and other materials
  • Activities associated with the dissemination of outputs

Projects involving artificial intelligence (AI)

Applications involving AI are eligible, and we expect you to provide a description and explanation of how the AI solution will support the NHS Long Term Plan, NHS strategic priorities, and/or wider government priorities. The NIHR has published guidance on definitions of AI.

Applicants are expected to provide a clear description of the proposed innovation and its AI or learning component, including details of its functionality, structure and intended use. You must clearly articulate why your innovation constitutes AI and at what stage of development it is. Details of any existing proof-of-concept, pilot, efficacy, usability or validation data for the proposed innovation and that of the AI component, if different to that of the proposed innovation, must be provided.

Details of any training datasets that were used should be included, and it needs to be stated if the AI component has been validated on an independent dataset. Regulatory information including the following should be provided

  • The intended use of your product: 'Intended use' means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials.
  • If your product qualifies as a medical device: 'Medical device' here means medical device, in vitro diagnostic medical device or active implantable medical device. Please justify your response with respect to the intended purpose of the product.

What we will not fund:

  • Work that involves animals, animal tissues or stem cells (if such studies are required as part of the project, we expect applicants to seek parallel funding to cover the work, and the details should be provided in the application form)
  • Projects involving small molecule drugs or cosmetic products 
  • Biomarker discovery 
  • Any work packages related to early stage or basic research
  • Minor or incremental changes to technologies in current clinical use, unless, for example, a technology is being repurposed from another healthcare area for which it has already received regulatory approval
  • Scale-up manufacture of the product needed to carry out a clinical evaluation (applicants must develop a plan for managing possible costs associated with these and provide the plan as part of the Stage 2 application)
  • Implementation costs other than those associated with research, including some of the costs incurred in order to put in place the technology
  • Evaluation of a fully developed product, which has already been adopted within the NHS or social care system
  • Digital health technologies that fall under Tier A and Tier B of the NICE Evidence Standards Framework for Digital Health Technologies, including wellness and wellbeing apps, technologies intended only for hospital information, administration, infrastructure and other related software
  • Professional training, including PhD fees and stipends, although costed time of the individual is allowed
  • Development of innovation or knowledge networks and healthcare technology cooperatives which aim to accelerate the development of innovative technology products

Tips for preparing a strong application

Applicants are encouraged to consider the following aspects, which address the assessment criteria of the programme, when preparing a project proposal:

The clinical or social care need, health economic case and impact on the NHS or social care system, patients and service users, must be clearly articulated. The proposed research must be highly relevant to the needs and healthcare priorities of the NHS and/or social care system and must respond to an existing clinical or social care need. A clear case has to be made on how the proposed technology might influence practice. Applicants should be aware of the latest national strategies and policies, including the NHS Long Term Plan, DHSC’s areas of interest and the NHS Core20PLUS5. For earlier stage proposals, evidence must be presented that a novel technology will be the ultimate output of the project, delivering a clear benefit to patients or service users and practice within the NHS or social care system. The need and advantages over the current gold standard and any constraints in adoption must be clearly articulated. For later stage proposals, this should include a strong health economic case that takes into account the clinical or care pathway that will be disrupted, highlighting advantages over the current gold standard and any constraints in potential adoption. The proposal should clearly explain how the ultimate output is the required evidence to support the adoption of the new technology. 

Applicants must demonstrate how the proposed device or technology presents a significant level of innovation, providing an advance over currently commercially available products. The proposal will need to articulate how the project will generate relevant data to drive adoption and how adoption of the technology would lead to a change in practice or better adherence to existing clinical guidelines.

Applicants will need to provide evidence to support the case for further development based on work to date and/or evidence from the literature. For projects focusing on real-world evaluation, applicants will also be required to provide evidence of safety and efficacy of the technology, including evidence from the literature, to support the case for the evaluation study. Details of key data generated in previous studies that support the project should be clearly described. Any claims or assertions made about the technology, including in the plain English summary, must have references provided.

The quality of the project plan, including the technological content and risk mitigation strategy, is integral to any application for funding. The proposed project must be focused on a specific clinical or social care application, with the characteristics of the proposed technology or intervention clearly defined. Project aims and objectives must be realistic in terms of time and resources requested. It is vital that there is as much detail as possible provided on research design and methodology. The project plan must adequately address aims and objectives, with a clear description of work packages, deliverables and milestones, and identify the main technical and regulatory barriers. Key risks to successful completion of the project should be clearly described, and appropriate steps to mitigate these risks must be proposed, such as delays to the supply of services/products from subcontractors or, where a clinical trial is involved, clear recruitment timelines including appropriate stop/go criteria must be proposed. If ethical approval for any part of the project is required, the timelines must be clearly indicated. Applicants are encouraged to discuss ethical approval requirements with their local Clinical Research Network and the Health Research Authority. Consideration should be given to inherent ethnic and other biases in developing, testing and evaluating medical devices and AI applications with specific cohorts and datasets, and applicants should follow evolving MHRA guidance on demonstrating how they intend to address bias. Guidance on increasing ethnic minority participation in trials is available through the government-funded INCLUDE framework.

For projects based in real-world settings, the proposed project must be focused on the evaluation of technology for implementation in health or care settings, and the challenges associated with this should be clearly discussed. 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 or care pathway that will be disrupted. Studies can focus on a single health or social care provider, but it would be ideal if impact on the wider system could be demonstrated, for example at an Integrated Care System level. It is expected that proposals describe real-world testing methods rather than a purely academic approach, and patients should have input from the outset. For example, rigorous but adaptable and pragmatic trial methodologies will be most suitable. The study should demonstrate the clinical utility of the intervention and should assess the technology against the appropriate comparator(s). 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. The evaluation should be designed taking into account how the technology fits into the clinical or care pathway. Plans for data and information governance should be in place.

When considering the evaluation strategy, applicants might find the following useful:

  • Familiarise yourself with the MRC Process Evaluation Guidance 
  • Include a co-applicant with experience in conducting process evaluations or implementation research
  • Identify key stakeholders likely to impact the implementation success (e.g. patients, healthcare professionals, administrators, managers, commissioners)
  • Explore contextual factors (i.e. barriers and enablers) among your stakeholders that may impact the success of implementation efforts and consider using a framework to guide data collection 
  • Identify and document implementation strategies that tackle the barriers and leverage the enablers (e.g. training, incentives, pathway re-design). For a compilation of implementation strategies see A refined compilation of Implementation strategies  
  • Assess implementation outcomes, in addition to patient and service outcomes, such as acceptability, reach, fidelity, and sustainability. See the following taxonomy of implementation outcomes. These can be assessed pre-, during and post-implementation across a range of methods (e.g. focus groups, interviews, observation, surveys, routinely collected data and audits).
  • Consider developing an implementation guide to support the spread and adoption of your technology.

The strength of the project team and project management arrangements must be clearly articulated. Arrangements for managing the project must be adequate and the roles of team members must be clearly described. Project teams are expected to have included expertise in all areas relevant to develop the proposed technology towards commercialisation and/or implementation. It is possible to request resources for external expertise, e.g. consultants for health economics or regulatory development. Teams are advised to appoint a project manager to coordinate and oversee project activities. Early career researchers are welcome to apply as a lead, as long as they have the appropriate skills to ensure project success. If necessary, a more established researcher can be added as a co-applicant. Similarly, where a proposal includes a joint lead organisation, justification must be given as to why this needs to be the case (please note that only one organisation will be party to the funding contract should the proposal be recommended for funding).

The application must also include an intellectual property (IP) and commercialisation strategy. All background and any potentially arising foreground IP must be described in the application. An initial freedom to operate opinion must be provided, referencing any third parties’ rights which may affect the development, implementation or commercialisation of the technology. Market opportunities, both domestic and global, and the expected impact of the proposed technology must be described. A strategy should be put forward as to how third party rights will be managed to allow for further development and commercial exploitation. IP arrangements between collaboration partners and with consultancies and sub-contractors must be regulated by appropriate agreements. A strategy for the commercial development of the technology must be presented, as well as a strategy for adoption of the technology into the NHS or other healthcare systems, or into the social care system. 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. If the technology is in earlier stages of development, adoption and exploitation plans can be one of the project’s deliverables. 

Taking into account the expected benefits of the proposed work and the level of funding requested, the proposal must provide 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 impact, so the requested amount should allow for the effective development of the technology. Any funds requested for NHS support and treatment costs must be appropriate and justified. Guidance on how to complete the finance section of funding applications is available in the Finance Guidance.

The NIHR expects active involvement of patients and the public (PPI) 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 or user groups for their application and engage with those groups at an early stage. A plain English summary is required 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.

Application process

Applications should be submitted to the Research Management System (RMS) before 1pm on the advertised closing date. We encourage early registration on the RMS as the system requires registration and validation of all co-applicant accounts. The terms and conditions under which the award will be made are set out in the NIHR standard research contract and are 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.

Applications are treated as confidential and all steps are taken to ensure confidentiality is maintained. 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. In line with the Department of Health and Social Care policy, i4i will publish summary minutes of committee meetings. Please refer to our Confidentiality Guidance for further details.

The i4i programme operates a two-stage application process. Assessment of applications is made by an expert committee, which comprises academic, clinical and commercial expertise (see our funding committees here). Applications are scored against the following assessment criteria:

  • Clinical or social care need, health economic case and impact on the NHS or social care system, patients and service users
  • Level of innovation
  • Case for further development based on work to date and evidence from the literature
  • Quality of the project plan, including the technical content, research methodology, evaluation methodology and risk mitigation strategy
  • Strength of the project team and management arrangements
  • Intellectual property (IP) and commercialisation strategy, including plans for adoption
  • Value for money
  • End user engagement and patient and public involvement (PPI)

Stage 1 applications will be shortlisted and successful applicants will be invited to prepare and submit a Stage 2 application. Details of the Stage 2 application process will be provided at that time and can also be found on the i4i website.

All Stage 2 applications are subject to independent peer review. Applicants will receive anonymised peer reviewer comments and will have the opportunity to respond in writing. All Stage 2 applicants must present their project proposal to the i4i funding committee at a committee meeting. The interview takes the form of a short presentation followed by a question and answer session. The application form, peer reviews, presentation and the applicant’s rebuttal are all taken into consideration by the i4i funding committee in reaching their funding decision.

Post-award process

Once your application has been recommended for funding, we will provide feedback as agreed with the i4i funding committee and undertake appropriate due diligence. Successful applicants are expected to start their project within the timeframe given in the funding notification, subject to the satisfactory completion of due diligence and a fully signed contract. The Department of Health and Social Care reserves the right to withdraw the funding offer at any time up to six months after the funding notification.

In addition to any changes to the work plan that may be requested by the i4i funding committee, further information may be requested, for example, on project finances, the project plan, project management, intellectual property and commercialisation. Funded applicants may be required to engage with members of the i4i funding committee or an independent advisor for the revision of the project plan or any other project elements.

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 use regular progress reports, email communication, phone calls and site visits (when possible) to evaluate progress and the achievement of deliverables and milestones.

Payments will normally be made quarterly in arrears (at the end of March, June, September and December), and you will be required to provide 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 payment interval; 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.

Privacy and data protection

The Research Management System (RMS) is hosted by Pulsant and managed by the NIHR Coordinating Centre (NIHRCC). The Data Controller for the website is the Department of Health and Social Care (DHSC). The Data Processor is the NIHRCC, based at LGC. 

The purpose for which personal information is collected through the RMS is to deliver the work of the NIHRCC 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 RMS is entirely voluntary and the personal information stored will be used solely by the NIHRCC, 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 NIHRCC 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 and Care 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 NIHRCC, 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 RMS.

If we change our privacy policy, for example, in response to changes in legislation, we will post details of any changes on our website. This will help ensure that you are always aware of what information we collect, how we use it, and under what circumstances, if any, we share it with other parties. In some circumstances, explicit consent to continue the use of the Services may be required. Otherwise, your consent to changes will be implied by your continued use of the Services. If you do not consent to the changes, then you must terminate your agreement as set out in section 12 of the Research Management System Terms and Conditions.

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.

Support and infrastructure for your application

The NIHR Infrastructure provides research expertise, specialist facilities, research delivery workforce and support services for delivering research and support to the life sciences industry. 

Support with research design and forging partnerships is available to all prospective applicants through the NIHR research support services and wider, detailed below. All prospective applicants are encouraged to engage with these services at the earliest opportunity.

  • NIHR's Research Support Service (RSS) - supports all aspects of developing and writing a funding application. Please note that the RSS is only available to applicants based in England, or with a project partner based in England. If that does not apply to you, you may wish to explore other services mentioned further down in this section.
  • NIHR support for the life sciences industry - help with finding and making great partnerships to strengthen your work. This service is available to all UK-based applicants and you may wish to contact them if you are seeking a partner.
  • NIHR Medtech and In vitro diagnostics Co-operatives (MICs) - can help to build a multi-disciplinary team to work collaboratively and ensure the right generation of evidence to support adoption in the NHS. HealthTech Research Centres (HRCs) have been commissioned to replace MICs from April 2024.
  • Clinical trial Units (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. CTUs may not be essential for all types of 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, 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.
  • Applicants from Scotland may access NHS Scotland Innovation Hubs and/or NHS Research Scotland 
  • Applicants from Northern Ireland may access The Northern Ireland Clinical Research Network

Applicants from Wales may access Health and Care Research Wales

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 before re-applying. 

Submissions to more than one NIHR programme

NIHR will not accept the same or substantially similar applications to more than one NIHR programme. If two similar applications are submitted, once the overlap is identified, the application that is most advanced through the funding process will continue and the second will not be taken further.

Similar applications will only be considered by two programmes concurrently if:

  • The aims and research proposals are substantially different
  • If successful, NIHR would be prepared to fund both proposals
  • The successful delivery of one project is not dependent on the other

Public involvement

NIHR has issued guidance for researchers about involving patients and the public in research. 

Information and resources to assist you can be found on the NIHR website, including: Briefing notes for researchers on how to involve patients/service users, carers and the public, including the definition of involvement engagement and participation; and Payments Guidance for researchers and professionals with information on budgeting for involvement.

There are several organisations that may be able to provide useful resources, advice and support on patient and public involvement in research:

The NIHR's Research Support Service (RSS) provides advice and support to researchers in England developing research proposals for submission to the NIHR and other national funding organisations for health and social care research.

The NIHR Centre for Engagement and Dissemination (CED) provides advice and a range of resources on patient and public involvement in research.

Learning For Involvement provides a wealth of training programmes and resources for public involvement in research. 

For best practice in PPI please see UK Standards for Public Involvement.

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 or Wales and involves NHS sites you should apply for HRA and HCRW approval. If your project is led from Northern Ireland or Scotland and involves NHS/HSC sites you should apply through the appropriate NHS/HSC permission process for that lead nation. Studies with sites in Northern Ireland or Scotland are supported through existing UK-wide compatibility systems where each country accepts relevant centralised assurances from national coordinating functions to avoid duplication. Guidance is available on IRAS.

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 which makes 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.

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.

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 in the Transparency agenda.

Appendix: Guidance on completing the application form

To submit an application, you must complete all the relevant sections of the online form available within the NIHRCC Research Management System (NIHRCC RMS).

The ‘System Help’ document found on the NIHRCC RMS’s web pages provides extensive step by step instructions on how to make use of the NIHRCC RMS.

Registration

Only registered users of the NIHRCC RMS can apply. Applicants new to using the NIHRCC RMS should register as a new user. Once logged into your account the RMS home page is the starting point for creating applications, accessing co-applications and updating contact information and professional details. 

Please ensure co-applicant accounts are created and validated on the RMS in good time before the submission deadline.

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 a 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 of 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 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 ‘Confirm’ 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. Contextual help is not designed to replace guidance. Mandatory questions are flagged with a red dot.

The system will prevent your co-applicants from accessing your application at the same time as you. This stops applicants and co-applicants from inadvertently making changes to the same part of the application at the same time and overwriting each other’s work.

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.

Following submission

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.