Invention for Innovation - Product Development Award Stage 1 Guidance for Applicants
This document provides guidance on completing an application for Stage 1 of the NIHR Invention for Innovation (i4i) Programme Product Development Awards (PDA) funding stream.
Applications are submitted online via CCF Research Management System. A Word version of the Stage 1 online Standard Application Form is available to be used as a template to prepare your answers. Please do not use this as an application form.
Please see the PDA Supporting Information.
Section 1: Application Summary Information
Provide details of the organisation who will be the contractor if the programme is funded.
The programme title should state clearly and concisely the proposed research. Any abbreviations should be spelled out in full.
Select the appropriate research type. If your proposed programme includes any element of primary research, please select ‘Primary Research’. If you are carrying out a new analysis of existing data, select ‘Secondary Research’. If you are not sure which category to select, choose the closest match to your project as this can be adjusted later.
Proposed Start Date
Note this should be from the 1st of the month regardless of whether this is a working day or not. Please be realistic about your possible start date taking account of the necessary contracting, and staff recruitment prior to starting your project.
Research Duration (months)
Ensure you include sufficient time to complete all aspects of the research including applications for regulatory approvals (where required) and the final report. Please note, i4i PDA projects can be up to a maximum duration of 36 months.
This field will automatically populate once you have entered the start date and research duration information.
Estimated Research Costs
Enter the total amount of research costs requested (not including NHS Support & Treatment costs).
Estimated NHS Support & Treatment costs or external (not NHS) intervention costs
Enter the total amount of NHS support and treatment costs associated with this proposal.
Please declare any conflicts or potential conflicts of interest that you or your co-applicants may have in undertaking this research, including any relevant, non-personal & commercial interest that could be perceived as a conflict of interest.
Agreement to terms and conditions
As lead applicant, please tick the box to confirm that the information entered into the application form is correct and that you take responsibility for overall management and delivery of the research.
Section 2: Lead Applicant Details
Complete your name, contact details and other requested information.
Section 3: The Research Team
Specify your (lead applicant) role in this research
Explain in addition to your role as Lead Applicant, the role that you will be undertaking in the research, e.g. coordination and project management, analysis, methodological input etc.
This refers to the percentage of your time that you will commit to this project. If you are funded as part of other NIHR projects that will be running concurrently, your time must not exceed 100% overall.
Joint Lead Applicant
Where appropriate and justified it is acceptable for the application to be led by joint Lead Applicants. Where this applies, please complete your name, contact details and other requested information.
Justification for Joint Lead Applicant and role in this research
Justification should be given to demonstrate why more than one person would be required to lead this research and how this brings added value to the application. Please also provide a brief overview of their role in the proposed research.
This refers to the percentage of your time that you will commit to this project.
NOTE: For application/contracting purposes, the joint lead applicant will be counted as a co-applicant.
Add details of all co-applicants and their specific role in the programme. Do not include collaborators, who should be mentioned (if necessary) in the Research Plan section of the form.
We encourage the inclusion of public co-applicants, where appropriate. Please include a clear description of their role and the reasons why a public co-applicant is joining the team. For further information please access the 'Public Co-Applicants in Research' guidance.
Co-applicants are those individuals with responsibility for the day to day management and delivery of the project and can include patients, carers and service users. Co-applicants, including public co-applicants, are considered part of the project team and are expected to share responsibility for its successful delivery. In contrast, Collaborators normally provide specific expertise on particular aspects of the project but do not share in the responsibility for the delivery of the project.
There should be a named person with appropriate skills and experience who is responsible for leading the PPI element within the project. This role should be an adequately costed and resourced research team member who is able to manage the PPI plans and related activities. Examples of the activities a PPI lead might undertake can be found in our definition and role of the designated PPI lead in a research team.
A maximum of 7 co-applicants is permitted (which includes the joint lead applicant if listed).
Section 4: Plain English Summary of Research
A plain English summary is a clear explanation of your research.
Many reviewers use this summary to inform their review of your funding application. They include clinicians and researchers who do not have specialist knowledge of your field as well as members of the public. If your application for funding is successful, the summary will be used on the National Institute for Health Research (NIHR) website and other related sites.
A good quality plain English summary providing an easy to read overview of your whole study will help:
- those carrying out the review (reviewers and committee members) to have a better understanding of your research proposal
- inform others about your research such as members of the public, health professionals, policy makers and the media
- the research funders to publicise the research that they fund.
If it is felt that your plain English summary is not clear and of a good quality then you may be required to amend it prior to final funding approval.
It is helpful to involve patients / carers / members of the public in developing a plain English summary.
When writing your summary consider including the following information where appropriate:
- aim(s) of the research
- background to the research
- design and methods used
- patient and public involvement
The plain English summary is not the same as a scientific abstract - please do not cut and paste this or other sections of your application form to create the plain English summary.
For further support and advice on writing a plain English summary, please contact your local Research Design Service (where applicable).
Section 5: Research Plan
Using all of the headings in the order presented below, please use this section to clearly explain your proposed research. Schematics, tables, illustrations, graphs, and other types of graphics can be embedded to clarify the research plan but they should not clutter the central narrative. Images do not count towards the overall word count but inclusion of them to overcome word limits is not permitted. Images may only be included within the 'Research Plan.' Images included in other sections will be removed from the application and not seen by reviewers.
As this is the main part of your application which will be considered by the reviewing committee, you should ensure that the information is accurate, succinct, clearly laid out and provides sufficient methodological detail. The overall amount of information that you can provide at this stage is limited to 3 - 4 pages (dependent on the type/complexity/scale of study proposed). (Limit: 3,000 words).
The NIHR expects appropriate and relevant involvement of patients/service users, carers and the public and other key stakeholders in the research it supports. It is essential to set out your plans to involve patients/service users, carers and the public in the Stage 1 application. Your patient/service user, carer and public involvement plans will be assessed by the funding committee including patient/service users, carers and public members.
Information and resources to assist you can be found on the NIHR website (a definition of patient and public involvement in research, briefing notes for researchers on how to involve patients/service users, carers and the public and payment guidance for researchers and professionals).
In this section it is important that you identify all stakeholders who are relevant to your research proposal. For each stakeholder group you need to be clear about how they benefit from your proposed research and, where appropriate, how they have been involved in the development of the application, as well as the plans for their involvement in the proposed research.
Digital Health Technologies
If you are developing a digital health technology or your technology contains a digital component you should consult the NICE Evidence Standards Framework for Digital Health Technologies and the NHS Digital Health Technology Standard describing:
- Evidence for Effectiveness for intended use (EfE)
- Evidence for Economic impact (Ei)
- Evidence for Safety, Security, Data Protection, Robustness, Stability, Interoperability, Usability and Accessibility
and ensure that you understand the requirements for your technology and provide evidence in your application that the evidence you will be generating is aligned to the standards.
What is the problem being addressed?
Provide a clear explanation of the problem to be addressed, the impact on patients, service users, carers, the public and health and care services, and how this project would fill a demonstrable gap.
Describe the current unmet need both within the NHS, social care and globally, and how your proposed solution would meet these needs.
Why is this research important in terms of improving the health and/or wellbeing of the public and/or to patients and health and care services?
It is essential that you clearly identify the health and care need your research meets or contributes to. Outline the anticipated value or contribution the intervention will provide, making a clear health economic case and indicating the anticipated timescales for any proposed impacts to be realised.
Describe how the proposed solution may have an impact on patient, service user, carer benefit (such as reduced mortality or morbidity, improved quality of life, reduced misdiagnosis, improved patient outcomes and experiences) and/or on future health care provision and long-term outcomes, comparing it with the existing standard of care and any other competing solutions in development or on the market. Describe why your approach is superior and what its benefit would be over existing NHS and/or social care practice.
Review of existing evidence - How does the existing literature support this proposal?
Explain why this research is needed now, in terms of time, relevance and competing solutions. We will only fund research which is informed by a review of the existing evidence.
Describe the level of innovation of the proposed technology, clearly stating the current level of development of the proposed solution, including what technical and clinical validation (proof of concept) you have to date, and what challenges remain to be addressed and overcome.
What is the research question /aims and objectives
Please summarise the research question, key aims and objectives.
Projects in this programme will vary considerably in their design; however, it is expected that applicants will clearly describe:
- The problem to be addressed
- The technology to be developed, stating the current status of development
- The key aims for the project, including key measures of success, project deliverables and project milestones
- The proposed project exit point.
Provide an expert summary of the project plan plus any additional points required to support statements made in the previous sections, and include any key references required to justify the points made (e.g. in the use of particular outcome measures or research design and methodology).
The project plan should include the following:
- The individual work packages within your project and your project milestones (a Gantt chart may be attached in the supporting information)
- A description of the main hurdles to be overcome technically, clinically and commercially
- The key risks to your project (including financial and IP risks) and the steps you will take to manage and mitigate these risks. Ensure that these risks are considered when defining milestones (the go/no go points for your project).
- An explanation of the role of key collaborators and sub-contractors involved in the research, as well as any patient, service user, carer and public leads (not previously listed as co-applicants). Sub-contractors provide external specialist services which cannot be provided by the organisation leading the project or its co-applicants or collaborators. Services include, for example, consultancy, design services, or the development and provision of specialist equipment. These costs can be requested for organisations providing these services in a territory that is outside England, but suitable justification is required.
- A description of how patients and the public, as well as other relevant stakeholders, including evidence users, have been involved in the development of the application, will actively be involved in the proposed research and how this involvement will benefit the project. Describe the reasons for the selected approach and any arrangements for training and support. If you are invited to submit a full application, your outline application will be assessed by a public panel member who will consider the patient and public involvement aspect of your proposal, and feedback will be provided for you to be considered in the full application.
- The NIHR expects appropriate and well-designed involvement of patients/service users, carers and the public and other key stakeholders in the research it supports. In the Stage 1 application, it is essential to show your plans for involving patients/service users, carers and the public at each appropriate stage of the research project lifecycle. For example, sitting on oversight committees, being a member of the research team involved in activities such as recruitment, data collection, analysis, producing study materials and sharing findings. Your PPI plans will be assessed by the funding committee which includes patient and public members. In the rare circumstances where PPI is not appropriate, a clear justification must be provided.
You should also outline how PPI has informed the development of the project so far. For example, the involvement of patients/service users, carers or the public in shaping the research question and study design. These activities could include the development of feasible, relevant and acceptable recruitment plans, data collection tools, information materials, outcome measures, follow-up, intervention design and delivery.
For a Stage 2 application, you will be asked how the PPI will be managed, reported and evaluated; whilst it is not necessary to provide the detail in Stage 1, early consideration should be given to these aspects.
You can find further resources to support the design of your PPI here. Your initial application will be assessed by a public committee member who will consider this aspect of your proposal.
Applicants are reminded that NIHR strategy encourages research which follows patient/service user, carer need. Researchers should clearly articulate how their research meets this objective, and how this contributes to the scientific rigour of their research study. Studies should recruit participants from geographical areas where patient/service user, carer need is greatest, including for example the rural and semi-rural areas where many older people live, and represent areas of diverse socioeconomic and ethnic diversity.
Equality, inclusion and diversity should also be properly considered when planning and describing the research, and evidenced in the application.
Every person eligible to take part in research should be offered the same opportunity of taking part in that research regardless of:
- Geographical location
- Gender reassignment
- Marriage and civil partnership
- Pregnancy and maternity
- Ethnicity - for example:
- The toolkit for increasing participation of BAME groups in health and care research
- The INCLUDE Ethnicity Framework, which aims to improve trial delivery for under-served groups
- Religion or belief
- Sexual orientation
- Socioeconomic status
- Access to health or social care
All NIHR applications are expected to include information about how this data will be collected.
In addition, applicants should demonstrate how these factors have been considered and addressed in their proposal, including steps taken to ensure the research sample is representative of the population the study is targeted at. Applicants need to explain who they are planning to recruit to ensure inclusivity of study participants and justify and explain any exclusions, for example by completing an Equality Impact Assessment. Costs associated with inclusivity, which may include, but are not limited to justified translation of research participant material into other relevant languages , would be expected and where appropriate should be included in the detailed budget section under ‘Other Direct Costs’. Additionally, applicants should demonstrate that all potential recruiting locations have been considered and the research is deliverable to those areas.
Please see the NIHR INCLUDE Guidance for more information about how to include under-served groups effectively:
Other helpful links:
Intellectual Property & Commercialisation
The definition of Intellectual Property (IP) includes patents, trademarks, designs, copyright (such as new software, checklists, scales, protocols, questionnaires, toolkits, guidelines or similar) and research tools (such as data analysis techniques, assays, cell lines, biomarkers, materials or equipment and devices).
Provide details of any existing IP and ownership arrangements, including patents or patent applications that are relevant to the project.
Indicate the procedure you used to evaluate your freedom to operate (FTO) position.
Please describe any FTO searches conducted to date and details of who carried them out.
Please list all related IP not owned by any of the applicants, including details relating to third party IP licensing requirements.
If no search has been conducted to evaluate FTO, please explain your rationale.
Provide details of any IP which will be produced or improved during the proposed research by any of the partners.
Provide details of how any new IP generated through the proposed research will be recognised, captured, managed and utilised, providing information on who will lead on dissemination and/or commercial exploitation.
Describe any competitive technologies that exist on the market or are currently in development and how your proposed technology is different.
Describe how long (in years) it will take from the project start date until the technology/solution is patient-ready, assuming that all necessary follow-on funding and commercial resources become available after the i4i project is successfully concluded.
Explain how you will ensure that your technology is adopted in the healthcare service. Please outline your intended strategy including the current and future barriers which may hinder the adoption of this technology and how these will be overcome.
Please outline the proposed route to market for your technology. Ensure that any regulatory hurdles arising are clearly indicated and how these may impact on the success of the technology. You should also indicate whether the project team or a third party (i.e. commercial partner) will be responsible for overcoming these hurdles.
Please note that our terms on the commercialisation of the research can be found in our Standard NIHR Research Contract.
Section 6: Uploads
One single-side A4 page, listing references used throughout your proposal.
If required, an additional supporting (single side of A4) document can be submitted with your application form (e.g., a flow diagram illustrating the study design and the flow of participants, gantt chart, diagrams, pictures etc.). If submitting a flow diagram, applicants should also describe complex interventions and controls as accurately and fully as possible within their diagram. If proposing an RCT, we advise you refer to the CONSORT statement and website for guidance. Alternatively, you may find the EQUATOR Network website useful. The PDF file should be submitted along with your application form.
Section 7: Administrative Contact details
Please provide the details of an administrative lead as a secondary point of contact for any queries relating to the application, should it be supported.
NOTE: This person does not need to be a co-applicant.
Section 8: Research and Development Office Contact Details
Please provide the contact details and job title of a person in the R&D office so that we are able to notify them of the outcome of this application including any associated feedback. In the event of this project being recommended for funding, we would also need to communicate with this person with regard to contract negotiations and general management of the project throughout its duration.
NOTE: Please note this person does not need to be included as a co-applicant.