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.
The i4i Addiction Mission: Innovation for Treatment and Recovery Awards is a stand alone call under the i4i programme focusing on the research, development, and testing in real world settings, of innovative digital, MedTech, and pharmaceutical interventions that support treatment and recovery for people with opioid or cocaine addictions.
Scope: Innovative product/intervention development
Entry point: Early to late stage. Early stage proposals must be post conceptual, pre-clinical, first-in-human, and prototyping. Late stage may be as late as post-launch or Clinical Trial Phase Four. Please see the Entry Point Eligibility Schematic below.
Exit point: By the end of the funded period proposals should, as a minimum:
- Have created a prototype intervention (if not present at the outset of the project),
- Conducted service user or other human testing,
- Have developed a continued development pathway for approval and UK roll-out.
Applicant eligibility: Any legal UK entity, regardless of size or sector, that has an innovative solution to improve patient outcomes in addiction healthcare and recovery. For instance, this call is open to commercial entities, NHS and Third Sector Service Providers, charitable organisations, local government bodies, as well as universities and research institutions.
Support for applicants: Support with research design and forging partnerships is available to all prospective applicants through the NIHR Research Support Service - RSS (previously supported by the Research Design Service) and Business Support Team respectively. All prospective applicants are encouraged to engage with these services at the earliest opportunity to get the best chance of success.
Maximum number of co-applicants: 7
Funding level: There is no upper funding limit for proposals. We would expect the majority of applications to request between £500,000 and £1.5m funding, however applicants are discouraged from compromising their ideas to meet this guideline, and applications will be considered on the overall merit and value for money they provide.
Project duration: Up to 36 months
Funding details: Commercial, third sector, local government 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).
The NIHR Invention for Innovation (i4i) Programme, in collaboration with the Office for Life Sciences (OLS), invites applications to the Addiction Mission: Innovation for Treatment and Recovery (AMI) Awards. Proposals must create valuable, innovative tools to help treat people with opioid or cocaine addictions and aid in their recovery.
The AMI Awards are a two-stage call inviting applications for projects up to 36 months in duration, with no upper funding limit.
The call will be open to all organisations which are UK legal entities, regardless of size or sector, that have an innovative solution to improve patient outcomes in addiction healthcare and recovery. For instance, this call is open to commercial entities, NHS and Third Sector Service Providers, charitable organisations, local government bodies, as well as universities and research institutions.
Innovations must focus on opioid or cocaine addiction. Innovations that are also applicable to other substances would be in scope only if they:
- primarily target opioid or cocaine addiction, and the focus of the proposed research project is to help treat people with opioid or cocaine addictions and aid in their recovery.
- support treatment or recovery for people with a pattern of polydrug use centred on opioid or cocaine addiction.
The focus of the NIHR Invention for Innovation (i4i) Addiction Mission: Innovation for Treatment and Recovery (AMI) Awards is to create valuable, innovative tools to help treat people with opioid or cocaine addictions and aid in their recovery.
This call aims to:
- Increase the number of companies and innovators developing and testing products in the UK system and supporting the sector to grow and thrive through UK based research and development.
- Improve outcomes for people in treatment and recovery for opioid or cocaine substance misuse through accelerating development and availability of innovative digital health, MedTech and pharmaceutical interventions.
Pre-award support for applicants
The i4i AMI Awards programme team held a webinar for applicants on 31 May 2023. If you would like to view the webinar please contact firstname.lastname@example.org.
Applicants are advised to review the NIHR standard research contract before application submission, and agree in principle with its core terms and conditions as they are non-negotiable.
If you are unsure as to your eligibility, please submit an enquiry form or email AMI@NIHR.ac.uk. Please note that the intention of the enquiry form, and any email correspondence, is to provide advisory support and it is not a requirement of the application process to complete one.
If you are considering applying and you are new to research or are not from a research institution, please do contact the appropriate NIHR research support services for free advice and support in finding potential research partners. This support is also available for experienced researchers.
NIHR Research Support Service (RSS)*: (previously the Research Design Service) The RSS provides support to health and social care researchers across England on all aspects of developing and writing a funding application, including research design, research methods, identifying funding sources and involving patients and the public. Advice is confidential and free of charge.
NIHR Business Design Team: The Business Development Team supports the life sciences industry to translate innovations into the UK health and care system by generating clinical evidence to progress your innovations towards market. We can support you to navigate the NIHR landscape within the UK research ecosystem, and provide expert matchmaking to the UK's leading experimental medicine experts.
All applicants are encouraged to engage with these support services at the earliest opportunity within their application process.
* Please note that the RSS is only available to applicants based in England. Applicants with a project partner based in England are able to access the service, but if you are based in the UK but outside of England, and are not partnered with an organisation based in England you may wish to explore the below services. The NIHR Business Development Team is available to all UK based applicants and you may wish to contact them in seeking a partner based in England.
- Applicants from Scotland may access The Drugs Research Network Scotland
- Applicants form Northern Ireland may access The Northern Ireland Clinical Research Network
- Applicants from Wales may access Health and Care Research Wales
Who we fund
Applications are welcome from all organisations which are a UK legal entity, regardless of size or sector, that have an innovative solution to improve patient outcomes in addiction healthcare and recovery.
- Applications are welcomed from both research institutions such as universities, and non-research institutions with a research arm such as commercial entities, NHS Service Providers, charitable organisations, and local government bodies etc.
- The lead organisation and collaborating organisations may be any of the types of eligible organisations listed below.
- Commercial organisations including large enterprises, SMEs, start-ups and newly spun-out companies;
- NHS service providers (including Trusts, community care providers and tertiary care centres, and Health and Social Care Trusts within Northern Ireland);
- Third Sector service providers;
- Primary care providers (including GP practices, primary care networks (PCNs) and GP Federations);
Please note that primary care providers should obtain formal sponsorship in order to apply for NIHR funding as the lead organisation, as per the Research Governance Framework
- Higher education institutions (including universities and research institutes);
- Not-for-profit organisations (including charities and Community Interest Companies);
- Local Authorities.
- Commercial organisations including large enterprises, SMEs, start-ups and newly spun-out companies;
- Applicant organisations can be based anywhere in the UK but the proposed research must:
- take place in the UK and
- show potential, and be appropriate, for roll out across the UK.
- To support the growth of innovators in this field, applications from early career researchers and innovators are particularly welcomed. They can apply as either the lead or joint-lead applicant together with a senior colleague fulfilling the other role. We are keen to encourage fresh ideas from new innovators and appropriate applications are welcomed from those with limited research experience when supported by an experienced, strong and multi-disciplinary team.
- Collaborations, where relevant, with patient organisations, drug treatment services, recovery services, housing services, members of the public and employers, are strongly encouraged. Consultation with individuals who have current or lived experience is expected.
- Multidisciplinary project teams, involving relevant collaborations between technology developers, data scientists and clinical staff, are particularly welcome. We encourage clinical applicants to not only comprise clinicians involved in addiction healthcare, but also those involved in a target setting or in the care of at-risk patient populations. The lead organisation should be best placed among the project parties, to lead the research, and either own or have full access to the background IP.
- Specialist services or expertise may be brought into the team through consultancy or sub-contract arrangements; however, appropriate justification must be provided.
- Collaborators and sub-contractors may be based outside of the UK if the required expertise or service cannot be reasonably contracted from within the UK.
- Involvement of international companies as subcontractor and/or collaborator, if working with a lead UK partner, are welcomed.
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 research, 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) in the design of clinical trials is strongly encouraged.
- 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. The research must be conducted in the UK and the focus must be on demonstrating ultimate patient benefit in the UK.
- Any in-kind contributions from collaborators must be clearly outlined.
What we fund
This funding supports activities associated with the research and development of transformative technologies for use in health and care settings.
Eligible Entry Points
Proposals are welcome for innovations at the majority of development stages. Please see the schematic below which illustrates the eligible entry points for this call.
Although, strictly speaking, a demonstrated proof of concept is not required, the most competitive proposals are expected to show data and evidence to support the case for further development.
Basic research projects are out of scope.
For AMI we will assess proposal entry points using Technology Readiness Levels. Technology Readiness Levels (TRLs) are a way to describe the maturity of a particular technology. There are 10 TRLs; 1 being the earliest level of readiness, and 10 being a technology which is freely available and fully developed for market.
Digital and MedTech/Non-pharmaceutical innovations must be beyond concept stage, and ideally have a prototype ready to test outside the laboratory. This is outlined in the schematic as TRL-4 and beyond. Prototype development, however, is acceptable as part of the initial stages of the proposal but this must be beyond the conceptual stages. Eligibility is outlined as TRL-3 and above. If you are yet to develop your prototype and are unsure if you meet TRL-3 please contact the AMI support team for advice.
Pharmaceutical innovations evaluated by clinical trials are eligible from Phase One (first-in-human), with the exception of Phase Three trials. Phase Three trials are not eligible due to their size and expense, however eligible adjuncts to existing Phase Three trials are welcomed. Please contact the AMI support team to discuss whether your Phase Three adjunct project is eligible.
Entry Point Eligibility Schematic
Entry points in red are out of scope, those in blue are within scope. If your project falls within an orange entry point, please do contact the AMI support team to discuss eligibility.
Entry Point Eligibility Schematic Description
If your innovation is technology: Technology Readiness Levels (TRL)
- Not eligible (red)
- Basic Research
- TRL-1: Idea, unproven, concept, no testing
- TRL-2: Concept and application formulated
- Basic Research
- Eligible (blue)
- Available data/evidence to support the case for further development
- Pre-Clinical Research
- TRL-3: First laboratory tests completed
- TRL-4: Small scale prototype built in a laboratory
- Manufacturing Validation / Late Pre-Clinical Research
- TRL-5: Large-scale prototype tested in unintended environment; simulation suite
- Clinical Research
- TRL-6: Performance-scale prototype tested in an intended environment close to expected performance
- TRL-7: Demonstrate innovation operating in an operational environment at pre-commercial scale, gaining regulatory approval
- Regulatory Clearance and Market Preparation
- TRL-8: First-of-Kind commercial innovation. Manufacturing and integration process outlined, gaining regulatory approval
- TRL-9 :Full commercial application: innovation available for consumers
- TRL-10: Innovation marketed; generation of real world evidence / impact evaluation.
If your innovation requires a Clinical Trial: Clinical Trials
- Not eligible (red)
- Pre-Clinical: Studies in the laboratory, animal models
- Phase Three: Large scale trials in patient population, clinical integration, long term impacts and evaluation of side effects, licensing
- Eligible (blue)
- Phase One: First-in-human, safety, proof of mechanism and concept
- Phase Two: First trials in patients, proof of efficacy and safety
- Phase Three Adjuncts: Eligible adjuncts to an existing, current Phase Three Clinical Trial
- Phase Four: Post-License, wider use, long term data, rare side effects
Types of intervention in scope for funding
Applications covering Digital, MedTech, and pharmaceutical interventions are all within scope.
The below list includes illustrative examples of interventions from which applications would be welcomed, but this is not an exhaustive list:
- Digital technology supporting interactive programmes to promote behaviour change and or maintenance for use by service users. For example:
- Treatment adjuncts: such as those which support delivery of supplementary treatment courses and content, monitoring of treatment and patient feedback, contingency management interventions, and/or approaches to encourage retention in treatment and the recovery journey.
- Structured, digitally delivered treatment: packages of drug focused interventions meeting care plan needs and goals of patients. This type of proposal would need to connect to trained healthcare professionals and include active interaction to meet clinical guidelines. These proposals could combine with multi-morbidity treatment pathways, for instance to align treatment for mental health conditions with addiction treatment.
- Relapse prevention/sustained recovery interventions: tracking, monitoring and feedback on ongoing medication and treatment plans, links to, or provision of mutual aid and support groups, tracking and flagging of relapse early warning signs, coaching sessions, or content to prevent relapse.
- Comprehensive assessment systems: to enable thorough remote assessment and determination of patient needs, optimal treatment pathways, and harm reduction strategies. These systems could provide opportunities to connect dual assessment of those with mental health conditions and substance misuse issues.
- Digital technologies within the above categories supported by Artificial Intelligence/Machine Learning (AI/ML), virtual reality and augmented reality, gamification, data analytics, or smartphone apps etc. would be welcomed.
- MedTech devices and solutions providing innovative or improved treatment delivery mechanisms for existing medicines. For example:
- Automated or timed dosing approaches (please note that innovations focusing on overdose events are not in scope).
- Novel administration approaches or routes leading to improved outcomes over existing approach in efficacy of medicine or patient adherence to treatment.
- Research and development of in vitro diagnostic devices as defined by the relevant EU Directives.
- Innovative combinations of interventions or products: Development, testing or validation of novel combinations in addiction healthcare. For instance, combining medications with psychological interventions delivered digitally.
- Pharmaceuticals for the treatment of drug addiction or to support in recovery including:
- Novel pharmaceuticals developed for substance misuse treatment or recovery at clinical trials (please see the entry point guidance for clinical trials).
- Licensed medicines or substances repurposed for substance misuse treatment or recovery.
Types of proposals in scope for funding through this call:
- Product development required to enable a technology for clinical use; work packages may comprise aspects of prototyping and manufacturing, engineering and performance testing.
- Feasibility studies, and/or studies to provide data relating to safety and effectiveness of an innovation, including first-in-human and pivotal clinical studies.
- Activities associated with the design and delivery of evaluations of innovative technologies in real world settings.
- Clinical utility studies: usability, tolerability and user acceptance of interventions.
- Research and development of techniques and/or technologies from a different industry sector which could have a potential impact if applied in substance misuse treatment and recovery.
- Studies exploring the repurposing of existing medicines and/or interventions which could help treat substance misuse or support recovery.
- Studies exploring innovative combinations of interventions.
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.
For your proposed innovation, please 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. Provide 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.
Include details of any training datasets that were used and clarify if the AI component has been validated on an independent dataset. Provide regulatory information including:
- 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:
- Proposals which do not primarily focus on outcomes for cocaine or opioid misuse treatment or recovery.
- Projects with no clear pathway to patient benefit.
- Work packages including animal or animal tissue studies. If animal or animal tissue 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.
- Proposals at Technology Readiness Level (TRL) 1-2 (concept and basic research stages) - please see the entry point eligibility schematic above.
- Proposals which focus only on in vitro diagnostics.
- Proposals for digital interventions that only provide health information, or only involve screening of patients without interactive, innovative involvement with treatment or recovery - such as treatment pathway determination and optimisation, data collection, storage or sharing.
- Wellness and/or Wellbeing applications unless specifically designed for opioid and/or cocaine addiction treatment and recovery.
- Phase Three clinical trials are out of scope, however eligible adjuncts to existing Phase Three trials are welcome.
- 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.
- Professional training, including PhD fees and stipends, although costed time of the individual is allowed.
- Interventions designed to prevent early drug use behaviour rather than treat, or aid in recovery from, existing addictions. These proposals are welcomed by the Innovation Fund to Reduce Demand for Illicit Substances Phase Two.
- Interventions that aid in detection of, and response to, or intervention in overdose events. These proposals were able to apply for funding through the SBRI Reducing Drugs Deaths Innovation Challenge.
- Development of new psychological treatment approaches, except where existing approaches are being adapted to be delivered via digital applications or technologies.
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 addiction treatment and recovery need, health economic case and impact on the NHS or social care system, patients or service users, must be clearly articulated. The proposed research must be highly relevant to the needs and priorities of the NHS and/or social care system and must respond to an existing clinical or social care need. 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 Core 20 PLUS 5. A clear case has to be made on how the proposed technology might influence practice. The need and advantages over the current gold standard and any constraints in adoption must be clearly articulated. 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.
Applicants must demonstrate how the proposed technology presents a significant level of innovation, providing an advance over currently available commercial 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. 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 addiction treatment and recovery 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 to add as much detail as possible 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 supply of services/products from subcontractors or, where a clinical trial is involved, clear recruitment timelines 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.
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 costed 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. Any evidence of previous product development should be included. It is possible to request resources for external expertise, for example 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 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 party’s rights which may affect the development or commercialisation of the technology. 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 with collaborators, consultancies and sub-contractors must be regulated by appropriate agreements. Market opportunities, both domestic and global, and the expected impact of the proposed technology must be described. A strategy for the commercial development of the technology must be presented. At the end of the project, where appropriate, applicants should deliver an exploitation plan, including further IP and commercialisation strategy and potential sources of onward funding or investment.
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 group(s) 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. It is to be expected that the PPI members working with your project, as either participants or as members of the research team, may be vulnerable adults, please ensure that this is considered in your PPI strategy.
It is to be expected that the PPI members working with your project, as either participants or as members of the research team, may be vulnerable adults. Safeguarding is everybody’s responsibility, please ensure this is considered in your PPI strategy, and that your proposal includes the time of a suitably qualified PPI Lead.
Applications should be submitted to the Research Management System (RMS) before 1pm on the advertised closing date. If your organisation has not applied for NIHR funding before, you will need to register your organisation, and your co-applicants organisations, on the Research Management System, and have received notification of validation, before you will be able to access the application form. Please ensure that you have registered your organisation, and your co-applicants organisations, well before you attempt to submit your application.
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). 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 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.
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.
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.
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 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.
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. Below are some examples of the support available should the support be relevant to your research plan proposal.
For more information on the industry offer and support, please contact the NIHR industry team.
Research Support Service - previously the Research Design Service
Applicants based in England may wish to seek advice on the content of an application via the Research Support Service (RSS). It is advisable to make contact as early as possible to allow sufficient time for discussion and a considered response.
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.
Clinical Trials Unit (CTU)
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.
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.
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
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 definition of involvement engagement and participation; and Payments Guidance for researchers and professionals with information on budgeting for involvement.
There are a number of organisations that may be able to provide useful resources, advice and support on patient and public involvement in research:
The Research Support Service (RSS) provides advice and support to researchers 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.
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 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.
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
In addition to the below technical guide, please read the AMI Guidance for Applicants document when completing your 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.
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.
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.