Internet Explorer is no longer supported by Microsoft. To browse the NIHR site please use a modern, secure browser like Google Chrome, Mozilla Firefox, or Microsoft Edge.

NIHR (i4i) & OLS Cancer Mission: Early Cancer Diagnosis Clinical Validation and Evaluation Call - Cancer Mission Supporting Information for Applicants


Published: 20 October 2023

Version: 2.0 December 2023

Print this document

Please be aware the OLS Cancer call closed on the 12/12/2023. Please contact the OLS Cancer team  if you have any further questions.


The NIHR Invention for Innovation (i4i) Programme, in collaboration with the Office for Life Sciences (OLS), invites applications for a £12m funding call aimed at the clinical validation (assessing that the approach does what it is intended to do, accurately and reproducibly in real people in a clinical setting) and evaluation (assessing whether the approach informs clinical practice in the intended way and/or has clinical impact on patient outcomes) of innovations with the potential to increase the early detection and diagnosis of cancer. We particularly welcome proposals that aim to directly address inequalities in stage of cancer diagnosis. Proposals may focus on a single cancer or target multiple cancer sites.
Types of eligible innovations include, but are not limited to, medical devices, in vitro diagnostics, NICE classified Tier C digital health solutions, software, artificial intelligence, behavioural interventions and new models of care.

i4i & OLS Cancer Mission: Early Cancer Diagnosis Clinical Validation and Evaluation Call

Key information

Scope: Clinical validation and evaluation of innovations targeted at increasing the early detection and diagnosis of cancer. Innovations aiming to target health inequalities in stage of cancer diagnosis are particularly welcome.

Entry point: Experimental proof-of-concept or laboratory-validated technology (TRL4).
Exit point: Clinically validated technology.
Applicant eligibility: HEI, SME, NHS or Third Sector Service Providers, charitable organisations and local government bodies based anywhere in the UK.
Collaborative requirements: At least one NHS provider needs to be involved in the project.
Funding level: No maximum but typical budget ranges from £0.5-£1.5m.
Project duration: Up to 36 months.


The aim of the call is to support the clinical validation and evaluation of breakthrough technologies that can increase the proportion of cancers which are detected earlier in the disease course and/or target health inequalities in stage of cancer diagnosis. The proposed research must show potential, and be appropriate, for the roll out and use in the UK. This call is open to both innovations that are approaching their first clinical human testing, as well as more mature products (which might have CE or UKCA mark) but need to generate further evidence before starting their real-world implementation, implementation research or confirmatory trials in the NHS. This call will also support innovations that have been already in use or clinically tested outside the UK, but that still require clinical validation and evaluation for cancer in the NHS settings. Repurposing of approaches from a cancer area to another (e.g., biomarkers well validated for different cancers, but needing more evidence in a new area; extend new pathways to other cancers, etc.),or from other therapeutic areas to cancer diagnosis and detection, is also welcome.
Applicants will be asked to evidence a future business development plan, including a strong implementation and commercial plan for the UK and NHS England.

Funding will be deployed to facilitate the generation of evidence on safety, test performance characteristics, clinical efficacy and/or effectiveness that can support regulatory approvals requirements and subsequent clinical implementation or implementation research.

Innovations which are the subject of proposals to this funding competition must already be at a minimum TRL of 4 and have been validated in the laboratory/the appropriate setting. Innovations must have a prototype for human testing ready, with only a minimum amount of product development required.

Proposals should include:

Combinations of the above to deliver behavioural interventions or new models of care are also welcome.

As part of demonstrating proof-of-concept, applicants are expected to have already generated experimental data to support the case for validation and evaluation and to illustrate technical feasibility. A strong element of patient and public involvement and end user engagement is a prerequisite for this call. 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, and 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 launch webinars, which are arranged for each competition and advertised on the call website, and/or to submit an enquiry form to check eligibility of their proposal. Please note that the intention of the enquiry form is to provide advisory support and it is not a requirement of the application process to complete one.

Who we fund

Applicant eligibility

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

  • Higher Education Institutions (HEI), including universities and research institutes
  • NHS and social care service providers, including Trusts, primary care and community care providers and tertiary care centres
  • 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 with at least one NHS organisation 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.

Engagement with other organisations and bodies in the cancer research infrastructure is encouraged.
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 United Kingdom.

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, clinical research, patient and public involvement, project management, intellectual property management, regulatory strategy and health economics.
  • 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 and the focus must be on demonstrating ultimate patient benefit in the UK. The call welcomes innovations generated and preliminary tested outside the UK, but applications will need to be led by a UK based collaborator.
  • 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

Funding is available for validation and evaluation of the potential to detect and diagnose earlier, in an NHS setting, either directly in individuals or in samples/data taken from these. We expect projects to involve a combination of the activities below rather than focusing on a single aspect.

This can include, but is not limited to, funding for:

  • Exploratory first-in-human and pilot clinical studies, including the establishment of safety, providing an understanding of device performance and effectiveness, defining its intended use and informing the design of any further studies. Only a minimal amount of product development is allowed in this call, if small adaptations are required to deliver the clinical trial
  • Integration of completed software/module into clinical application landscape (e.g. in preparation for trials and data collection)
  • Feasibility studies for technologies developed in a sector other than health
  • Pivotal clinical studies for the evaluation of safety and effectiveness of a device in its intended use
  • Clinical utility studies to explore usability, tolerability and user acceptance
  • Patient and public involvement and end user engagement
  • CE/UKCA marking and other regulatory requirements, including work towards QMS development and the Clinical Evaluation Report. Technologies that already have CE marking or equivalent may also apply if further validation and evaluation is required to progress to another class
  • Health economic analysis, such as a budget impact or market analysis to build or improve the economic case
  • 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
  • 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, OLS Cancer mission 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:

  • Therapeutics including vaccines or cell/gene therapies
  • Apps concerning general wellness and/or wellbeing not specifically concerned with cancer symptom recognition and reporting
  • Innovations with limited or no impact on early diagnosis rates
  • Innovations mainly focused at increasing diagnostic efficiencies rather than increasing the proportion of cases diagnosed early
  • Innovations requiring further substantial product development iterations before starting the clinical testing
  • 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)
  • Any additional 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)
  • Products that have shown proven efficacy or clinical effectiveness or are already used in standard routine care in the UK health system for the cancer(s) which is the focus of the proposal
  • Digital health technologies that fall under Tier A and Tier B of the NICE Evidence Standards Framework for Digital Health Technologies, including 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 potential for the proposal to increase the proportion of cancers which are detected earlier in the disease course and/or target health inequalities in stage of cancer diagnosis. Applicants must provide a tangible evidence base for their innovation that is commensurate with the level of development of the product and should justify the clinical validation/evaluation being the appropriate next step for the innovation. Applicants should also specify the mechanism through which the innovations will improve early diagnosis (e.g. cancer detection in asymptomatic population, encourage early symptomatic patients to self-assess/present earlier, support ongoing engagement and completion of diagnostic pathways, address health inequalities in stage of cancer diagnosis between socioeconomic, geographic, demographic or other subpopulations, etc.). Applications must identify what clinical pathways will be affected by the intervention and what the expected impact on them will be.

The specific unmet need in early cancer detection and diagnosis and its 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 Core20PLUS5. 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.

Applicants must demonstrate how the proposed technology presents a significant level of innovation, providing an advance over currently available commercial products and standard of care approaches. 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 validation and evaluation 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 characteristics of the proposed technology or intervention must be 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, clear recruitment timelines must be proposed. Given the nature of the projects, it is likely that ethical approvals will be required, and the timelines for this must be clearly indicated. Applicants are encouraged to discuss ethical approval requirements with their local Clinical Research Network and the Health Research Authority. The trial design must include the rationale for the chosen methodology and recruitment targets must have statistical significance and be achievable.

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 should be provided, referencing any third party’s rights which may affect the commercialisation of the technology. A strategy should be put forward as to how third party rights will be managed to allow for 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 validation or evaluation 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.

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.

This call operates a one stage application process. Assessment of applications at the .shortlisting stage is made by a pool of experts, which comprises academic, clinical, methodological and commercial expertise (see our funding committees). Applications are scored against the following assessment criteria:

  • The potential for the proposal to increase the proportion of cancers which are detected earlier in the disease course and/or target health inequalities in stage of cancer diagnosis
  • 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 validation/evaluation 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)

All shortlisted applications are subject to independent peer review. Applicants will receive anonymised peer reviewer comments and will have the opportunity to respond during an interview held by an independent Committee. 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 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.

Post-award process

Once your application has been recommended for funding, we will provide feedback as agreed with the 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 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 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. 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

Applicants may wish to seek advice on the content of an application via their regional 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.

Resubmission policy

Although we do not prohibit the submission of applications which were submitted unsuccessfully in previous application rounds, applicants should recognise that the original applications were judged to be uncompetitive in that round, or significantly flawed, and are therefore likely to need substantive modification to have a realistic chance of being funded in future competitions. Previously unsuccessful applicants should therefore pay particularly close attention to any specific feedback provided prior to re-applying.

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 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.

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.


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.

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.