Funding opportunity

Funding opportunity: Gap Fund for early-stage development of new healthcare interventions

Start application

Apply for funding to generate critical data that builds confidence in the development strategy for a new or repurposed medicine, medical device, diagnostic test, or other medical intervention.

The concept for the new product should already be backed by other funding. The Developmental Pathway Gap Fund should be used to produce the crucial missing evidence (a gap in knowledge) needed to rapidly de-risk onward development or determine failure.

The Gap Fund sits between the smaller Impact Acceleration Account (IAA) funding and the more substantial Developmental Pathway Funding Scheme (DPFS).

Who can apply

Before applying for funding, check the Eligibility of your organisation.

UK Research and Innovation (UKRI) has introduced new role types for funding opportunities being run on the new UKRI Funding Service.

For full details, visit Eligibility as an individual.

Who is eligible to apply

To be eligible to apply for this funding opportunity you must:

  • be employed by an eligible research organisation
  • show that you will direct the project and be actively engaged in the work
  • be looking to generate critical preliminary data to build confidence in the development strategy for a new medicine, repurposed medicine, medical device, diagnostic test, or other medical intervention development

If you do not have a contract of employment for the duration of the proposed project, by submitting an application the research organisation is confirming, if it is successful:

  • contracts will be extended beyond the end date of the project
  • all necessary support for you and the project will be provided, including mentorship and career development for early career researchers

Who is not eligible to apply

You are not eligible to apply for this funding opportunity as a project lead if you are based at an international research organisation. This does not include MRC Unit The Gambia or MRC/UVRI Uganda Research Unit at the London School of Hygiene and Tropical Medicine that are eligible to apply as project lead. Before applying for funding, check the Eligibility of your organisation.

International applicants

You can include international applicants as project co-leads (international), where they will make a major intellectual contribution to the design or conduct of the project. The contribution and added value to the research collaboration should be clearly explained and justified in the application, see Applicant and team capability to deliver.

Equality, diversity and inclusion

We are committed to achieving equality of opportunity for all funding applicants. We encourage applications from a diverse range of researchers.

We support people to work in a way that suits their personal circumstances. This includes:

  • career breaks
  • support for people with caring responsibilities
  • flexible working
  • alternative working patterns

Find out more about equality, diversity and inclusion at UKRI.

What we're looking for

Scope

You can apply for academically led translational projects that aim to undertake a focused package of work that will bridge the gap between the inception of a new idea and substantive funding through schemes such as the MRC Developmental Pathway Funding Scheme to:

  • help prevent disease
  • help improve speed and accuracy of diagnosis of disease
  • develop new treatments for disease
  • help to improve outcome monitoring of patients receiving treatment
  • help to improve the management of diseases and conditions

All human diseases and medical interventions are eligible for support, both in the context of UK healthcare and addressing global health issues.

Your project should have already explored a new concept and generated some data in support of the approach. Your application should clearly articulate:

  • the core concept of the project
  • the critical gap that needs to be addressed
  • an explanation of how the proposed plan will address this critical gap
  • the challenges and issues involved in onward development

This fund will provide small scale funding to generate critical data needed prior to seeking more substantive funding. A non-exhaustive list of examples of the types of projects that could be supported include:

  • elements of therapeutic discovery, quantification, and validation
  • development of an initial prototype
  • early prototype testing
  • initial biomarker validation
  • vector identification or optimisation
  • hit expansion medicinal chemistry

In exceptional circumstances, you can submit follow on applications where you can justify the need for continued support. However, in most cases a positive outcome of the proposed work should be sufficient to allow submission of a longer and larger application, potentially to DPFS.

For more information on the background of this funding opportunity, go to the ‘Additional information’ section.

Applications from research organisations who are not recipients of an MRC Impact Accelerator Account (IAA) award may use this funding opportunity to apply for more preliminary studies. The scale and scope of the request should reflect a project more in line with earlier stages of research.

Applicants should highlight within the application that they are applying for an IAA-like project and that their research organisation does not provide this opportunity.

Activities we support

You can apply for funding for work on novel:

  • new small molecule medicines
  • vaccines for infectious or non-infectious disease
  • biologics (antibodies, peptides, proteins)
  • advanced therapeutics (for example, gene therapy, cell therapy, RNA therapy, nucleic acid therapy and T-cell therapy)
  • complex medicines for example PROTACS, molecular glues and antibody-drug conjugates
  • regenerative medicine approaches
  • repurposing clinical studies or using existing therapies for new indications
  • medical devices
  • digital healthcare, app development or artificial intelligence
  • diagnostics (including biomarker validation)
  • medical imaging technology
  • surgical techniques or tools
  • behavioural and psychological interventions
  • radiotherapy and radiation protocols

Activities we do not support

This funding opportunity will not support:

  • fundamental or investigative research that is not linked to a product development plan (supported by the MRC science areas)
  • clinical studies where the main aim is to investigate disease mechanism (supported by the MRC Experimental Medicine Panel)
  • generation of preliminary concept data (supported by the MRC Impact Accelerator Accounts)
  • pre-clinical safety and toxicology studies (supported by the MRC Developmental Pathway Funding Scheme)
  • early-phase clinical trials (supported by the MRC Developmental Pathway Funding Scheme); note that clinical feasibility studies within the cost limits of the Gap Fund may be considered for Gap funding. Contact the Gap Fund mailbox prior to submission)
  • late-phase clinical trials (supported by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation and NIHR Health Technology Assessment programmes)
  • interventions aiming to improve NHS service delivery (supported by NIHR)
  • late-phase global health trials (supported by applied global health research board)
  • same or similar applications that have previously been rejected by other MRC funding panels in the last 12 months

Duration

The duration of this award is between six and 24 months. Justification of the timescale and resources needed in the context of the proposed work needs to be provided and duration of request should reflect this.

Projects should start one to six months after the funding decision date.

Funding available

The full economic cost (FEC) of your project can be between £50,000 and £300,000.

We will provide funding at 80% of the FEC. If this limit is exceeded, your application will be rejected by the MRC during the initial checks stage.

What we will fund

You can request funding for costs such as:

  • a contribution to the salary of the project lead and co-leads
  • support for other posts such as research and technical staff
  • research consumables
  • equipment
  • travel costs (conference attendance costs are not acceptable for this award)
  • data preservation, data sharing and dissemination costs
  • estates and indirect costs

You can also request costs for work to be undertaken at international organisations by international project co-leads. We will fund 100% of the FEC.

The total of such costs requested for international applicants from developed countries (those not on the OECD DAC List of ODA Recipients), India and China must not exceed 30% of the total resources requested.

There is no cap on costs requested for international applicants from DAC list countries.

For more information on international costs and what we will and will not fund see costs we fund-overseas and the Collaborate with Researchers in Norway guidance.

What we will not fund

We will not fund:

  • costs for PhD studentships
  • publication costs
  • funding to use as a ‘bridge’ between grants
  • costs associated with applying for IP protection, for example, patent filing
  • conference costs

Team project partner

You may include team project partners that will support your research project through cash or in-kind contributions, such as:

  • staff time
  • access to equipment
  • sites or facilities
  • the provision of data
  • software or materials
  • recruitment of people as research participants
  • providing samples, such as human tissue, for the project

Each project partner must provide a statement of support. If your application involves industry partners, they must provide additional information if the team project partner falls within the industry collaboration framework.

Find out more about subcontractors and dual roles.

Who cannot be included as a team project partner

Any individual included in your application with a core team role cannot also be a project partner.

Any organisation that employs a member of the application core team cannot be a project partner organisation; this includes other departments within the same organisation.

If you are collaborating with someone in your organisation, consider including them in the core team as project co-lead, or specialist. They cannot be a project partner.

Supporting skills and talent

We encourage you to follow the principles of the Concordat to Support the Career Development of Researchers and the Technician Commitment.

Trusted Research and Innovation (TR&I)

UK Research and Innovation (UKRI) is committed in ensuring that effective international collaboration in research and innovation takes place with integrity and within strong ethical frameworks. Trusted Research and Innovation (TR&I) is a UKRI work programme designed to help protect all those working in our thriving and collaborative international sector by enabling partnerships to be as open as possible, and as secure as necessary. Our TR&I Principles set out UKRI’s expectations of organisations funded by UKRI in relation to due diligence for international collaboration.

As such, applicants for UKRI funding may be asked to demonstrate how their proposed projects will comply with our approach and expectation towards TR&I, identifying potential risks and the relevant controls you will put in place to help proportionately reduce these risks.

Further guidance and information about TR&I, including where applicants can find additional support, can be found on UKRI’s website.

How to apply

We are running this funding opportunity on the new UK Research and Innovation (UKRI) Funding Service so please ensure that your organisation is registered. You cannot apply on the Joint Electronic Submissions (Je-S) system.

The project lead is responsible for completing the application process on the Funding Service, but we expect all team members and project partners to contribute to the application.

If the lead research organisation is an NHS organisation, check it is available in the Funding Service. You are encouraged to check this early as there may be additional steps for the organisation to be set up before you can apply.

Only the lead research organisation can submit an application to UKRI.

To apply

Select ‘Start application’ near the beginning of this Funding finder page.

  1. Confirm you are the project lead.
  2. Sign in or create a Funding Service account. To create an account, select your organisation, verify your email address, and set a password. If your organisation is not listed, email support@funding-service.ukri.org
    Please allow at least 10 working days for your organisation to be added to the Funding Service. We strongly suggest that if you are asking UKRI to add your organisation to Funding Service to enable you to apply to this Opportunity, you also create an organisation Administration Account. This will be needed to allow the acceptance and management of any grant that might be offered to you.
  3. Answer questions directly in the text boxes. You can save your answers and come back to complete them or work offline and return to copy and paste your answers. If we need you to upload a document, follow the upload instructions in the Funding Service. All questions and assessment criteria are listed in the How to apply section on this Funding finder page.
  4. Allow enough time to check your application in ‘read-only’ view before sending to your research office.
  5. Send the completed application to your research office for checking. They will return it to you if it needs editing.
  6. Your research office will submit the completed and checked application to UKRI.

Where indicated, you can also demonstrate elements of your responses in visual form if relevant. You should:

  • use images sparingly and only to convey important information that cannot easily be put into words
  • insert each new image onto a new line
  • provide a descriptive legend for each image immediately underneath it (this counts towards your word limit)
  • ensure files are smaller than 5MB and in JPEG, JPG, JPE, JFI, JIF, JFIF, PNG, GIF, BMP or WEBP format

Watch our research office webinars about the new Funding Service.

For more guidance on the Funding Service, see:

References

Applications should be self-contained, and hyperlinks should only be used to provide links directly to reference information. To ensure the information’s integrity is maintained, where possible, persistent identifiers such as digital object identifiers should be used. Assessors are not required to access links to carry out assessment or recommend a funding decision. Applicants should use their discretion when including references and prioritise those most pertinent to the application.

References should be included in the appropriate question section of the application and be easily identifiable by the assessors for example (Smith, Research Paper, 2019).

You must not include links to web resources to extend your application.

Deadline

We must receive your application by 13 November 2024 at 4:00pm UK time.

You will not be able to apply after this time.

Make sure you are aware of and follow any internal institutional deadlines.

Following the submission of your application to the funding opportunity, your application cannot be changed, and applications will not be returned for amendment. If your application does not follow the guidance, it may be rejected.

Personal data

Processing personal data

MRC, as part of UKRI, will need to collect some personal information to manage your Funding Service account and the registration of your funding applications.

We will handle personal data in line with UK data protection legislation and manage it securely. For more information, including how to exercise your rights, read our privacy notice.

Publication of outcomes

MRC, as part of UKRI, will publish the outcomes of this funding opportunity at board and panel outcomes.

If your application is successful, we will publish some personal information on the UKRI Gateway to Research.

Summary

Word limit: 550

In plain English, provide a summary we can use to identify the most suitable experts to assess your application.

We usually make this summary publicly available on external-facing websites, therefore do not include any confidential or sensitive information. Make it suitable for a variety of readers, for example:

  • opinion-formers
  • policymakers
  • the public
  • the wider research community

Guidance for writing a summary

Clearly describe your proposed work in terms of:

  • context
  • the challenge the project addresses
  • aims and objectives
  • potential applications and benefits

Core team

List the key members of your team and assign them roles from the following:

  • project lead (PL)
  • project co-lead (UK) (PcL)
  • project co-lead (international) (PcL (I))
  • specialist
  • grant manager
  • professional enabling staff
  • research and innovation associate
  • technician
  • visiting researcher
  • researcher co-lead (RcL)

Only list one individual as project lead. If you include more than one project lead your application will fail at the checking stage.

Find out more about UKRI’s core team roles in funding applications.

Application questions

Background to application

Word limit: 700

What is the background of this application and the evidence supporting the proposed solution? Describe the gap in funding as outlined in the description of this question.

What the assessors are looking for in your response

Ensure that you structure your response to this question with the following headings:

  • background overview
  • the ‘Gap’
  • previous funding and funders
  • resubmission
  • correspondence with MRC
Overview

Provide a brief overview of the scientific background of your application.

The Gap

Provide a brief but clearly articulated overview of how your project aims to address a critical missing piece of information that would support future applications for substantial funding, such as the Developmental Pathway Funding Scheme (DPFS).

If you fail to include a paragraph articulating “The Gap” your application may be rejected during the initial stage of the application assessment process.

Your description of ‘The Gap’ should be a minimum of 50 words long.

Previous funding and funders

Provide information related to any of your previously funded applications (including details of the funder), where this previous work has enabled and informed the work proposed in your application, specifying any previous UKRI application references.

If there is no relation between any of your previously funded work and your current application, you should still include the “Previous funding and funder” heading, indicating N/A to show a response to this question is not applicable.

Resubmission

You are required to identify if your application is a resubmission and include any invitations from the Medical Research Council (MRC) permitting your resubmission and how the proposed work has developed.

Correspondence with MRC

Reference any other correspondence with MRC relevant to and regarding your current application

You may demonstrate elements of your responses in visual form if relevant. Further details are provided in the Funding Service.

Opportunity and market

Word limit: 1,000

What is the opportunity or challenge, you are seeking to address?

What the assessors are looking for in your response

Ensure you describe:

  • the health or clinical need you are seeking to address
  • how your work could lead to the development of a new or improved prototype, product, service or technology
  • how meeting this need could significantly reduce disease burden or alleviate an important bottleneck
  • the competing solutions and their status, including whether similar or complementary research is being taken elsewhere
  • the key competitive advantages of your proposed solution
  • the potential market for your proposed solution

Approach

Word limit: 1,650

How has the idea or solution been developed to date and what is the proposed approach for further development?

What the assessors are looking for in your response

Explain how you have designed your approach so that it:

  • is effective and appropriate to achieve your objectives
  • is feasible, and comprehensively identifies any risks to delivery and how they will be managed
  • uses a clearly written and transparent methodology (if applicable)
  • will maximise translation of outputs into outcomes and impacts
  • describes how your, and if applicable your team’s, research environment (in terms of the place and relevance to the project) will contribute to the success of the work

Ensure you describe how the idea or solution has been developed to date and what the proposed approach for further development is.

You should outline:

  • the previous work and current status of the innovation or technology and how the proposed work will build upon and progress its development
  • the critical data to be generated as the project endpoint that will maximise translation of outcomes and transform the chance of attracting onward investment
  • the expertise or any consultancy required to deliver the proposed work

Provide a summary of the project workplan, accompanied by an embedded Gantt chart or similar aide to support your application. You should outline:

  • project specific deliverables, including proposed success criteria
  • the resourcing necessary to deliver the proposed work
  • the overall timeframe of the project

You should not use the project plan to include information which should be detailed in the other sections of your application.

Ensure that you describe the methodology and experimental design. This should include:

  • the use of animals or patients, including justification for why particular animal models or clinical populations have been chosen and any considerations given to diversity
  • any consultation with a statistician or methodology hub to the development of the application
  • the access you will have to statistical support during the project
  • the statistical analysis plans, the proposed sample sizes in sufficient detail for the replication of any power calculation
  • the anticipated effect sizes and variability
  • potential sources of bias and describe the strategies that will be adopted to minimise their effects

Please refer to the MRC guidance for applicants for further information.

Use the ‘Research involving the use of animals’ section to provide information on the rationale for using animals, choice of species, welfare and procedure severity.

The National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs) have developed a free online tool to guide researchers through the design of their experiments. It helps to ensure that researchers use the minimum number of animals consistent with their scientific objectives, methods to reduce subjective bias, and appropriate statistical analysis.

References may be included within this section.

You may demonstrate elements of your responses in visual form if relevant. Further details are provided in the Funding Service.

Applicant and team capability to deliver

Word limit: 1,650

Why are you the right individual or team to successfully deliver the proposed work?

What the assessors are looking for in your response

Evidence of how you, and if relevant your team, have:

  • the relevant experience (appropriate to career stage) to deliver the proposed work
  • the right balance of skills and expertise to cover the proposed work
  • the appropriate leadership and management skills to deliver the work and your approach to develop others
  • contributed to developing a positive research environment and wider community

You may demonstrate elements of your responses in visual form if relevant. Further details are provided in the Funding Service.

The word count for this section is 1,650 words: 1,150 words to be used for R4RI modules (including references) and, if necessary, a further 500 words for Additions.

Use the Résumé for Research and Innovation (R4RI) format to showcase the range of relevant skills you and, if relevant, your team (project and project co-leads, researchers, technicians, specialists, partners and so on) have and how this will help deliver the proposed work. You can include individuals’ specific achievements but only choose past contributions that best evidence their ability to deliver this work.

Complete this section using the R4RI module headings listed. Use each heading once and include a response for the whole team, see the UKRI guidance on R4RI. You should consider how to balance your answer, and emphasise where appropriate the key skills each team member brings:

  • contributions to the generation of new ideas, tools, methodologies, or knowledge
  • the development of others and maintenance of effective working relationships
  • contributions to the wider research and innovation community
  • contributions to broader research or innovation users and audiences and towards wider societal benefit
Additions

Provide any further details relevant to your application. This section is optional and can be up to 500 words. You should not use it to describe additional skills, experiences, or outputs, but you can use it to describe any factors that provide context for the rest of your R4RI (for example, details of career breaks if you wish to disclose them).

Complete this as a narrative. Do not format it like a CV.

References may be included within this section.

UKRI has introduced new role types for funding opportunities being run on the new Funding Service.

For full details, see Eligibility as an individual.

Project partners

Add details about any project partners’ contributions. If there are no project partners, you can indicate this on the Funding Service.

A project partner is a collaborating third party organisation who will have an integral role in the proposed research. This may include direct (cash) or indirect (in-kind) contributions such as expertise, staff time or use of facilities.

Important note: If your application includes industry project partners, you will also need to complete the Industry Collaboration Framework (ICF) section. Find out more about ICF.

You must ensure that any third-party individual or organisation you include within the Funding Service as a project partner, also provides you with a supporting email or letter of support (see next section ‘Project partners: letters or emails of support’).

The individual named as the project partner contact, cannot be included in your application as a member of the core team, in any core team role.

The project partner organisation cannot be an applicant organisation, where any member of the core team is based. For example, you cannot include a different department based within the applicant organisation as a project partner.

If an individual or organisation outside the core team is responsible for recruitment of people as research participants or providing human tissue for this project, list them as a project partner.

Add the following project partner details:

  • the organisation name (searchable via a drop-down list or enter the organisation’s details manually, as applicable)
  • the project partner contact name and email address
  • the type of contribution (direct or in-direct) and its monetary value

If a detail is entered incorrectly and you have saved the entry, remove the specific project partner record and re-add it with the correct information.

If there are specific circumstances where project partners do require funding for minor costs such as travel and subsistence, these project partner costs should be claimed and justified within the resources and costs section of your application.

For audit purposes, UKRI requires formal collaboration agreements to be put in place if an award is made.

Project partners: letters (or emails) of support

Word limit: 10

Upload a single PDF containing the letters or emails of support from each partner you named in the ‘Project partners’ section. These should be uploaded in English or Welsh only.

What the assessors are looking for in your response

Enter the words ‘attachment supplied’ in the text box, or if you do not have any project partners enter ‘N/A’.

What supporting statements we are looking for

Important note: We are only looking for you to provide project partner letters or emails of support from the following:

  • a third-party individual
  • a third-party organisation

Third party means the individual and organisation must not be involved in the application core team. You must ensure that any project partners providing a supporting document, are also added to the ‘Project partners’ section within the Funding Service.

Ensure you have prior agreement from project partners so that, if you are offered funding, they will support your project as indicated in the ‘Project partners’ section.

For audit purposes, UKRI requires formal collaboration agreements to be put in place if an award is made.

What supporting statements we are not looking for

We are not looking for you to provide any letters or emails of support from individuals or organisations included in your application core team (this includes other departments within the same organisation). Any individual or organisation included in your application with a core team role cannot also be a project partner.

Do not include any other statements or any other type of information we have not requested, including letter or emails of support from colleagues simply expressing supportive opinions. We only expect letters or emails of support from your third-party project partners uploaded to this section.

If you include any information not requested by MRC, your application will be rejected.

Supporting document guidance for third party project partners

Each project partner supporting letter or email you provide, should:

  • be no more than two A4 pages
  • confirm the partner’s commitment to the project
  • clearly explain the value, relevance, and possible benefits of the work to them
  • describe any additional value that they bring to the project
  • include the name of the project partner organisation and contact information (this should match the partner contact and organisation name details you must add to the ‘Project partners’ section)

Project partners letters and emails of support are not required to be on headed paper or include handwritten signatures (electronic signatures are acceptable from the nominated partner contact).

Project partner responsibility for the recruitment of people

If the project partner is responsible for the recruitment of people as research participants or providing human tissue their letter or email of support should include:

  • agreement that the project partner will recruit the participants or provide tissue
  • confirmation that what is being supplied is suitable for the proposed work
  • confirmation that the quantity of tissue being supplied is suitable, but not excessive for achieving meaningful results (if applicable)
Multiple project partners

If you have multiple project partners, you should:

  • ensure each separate letter or email of support, does not exceed two pages of A4
  • consolidate all the supporting documents provided by each project partner into a single PDF file before uploading
  • ensure the PDF does not exceed the maximum file size of 8MB

For the file name, use the unique Funding Service number the system gives you when you create an application, followed by the words ‘Project partner’.

The Funding Service will provide document upload details when you apply. If you do not have any project partners, you will be able to indicate this in the Funding Service.

Ensure you have prior agreement from project partners so that, if you are offered funding, they will support your project as indicated in the ‘Project partners’ section.

For audit purposes, UKRI requires formal collaboration agreements to be put in place if an award is made.

Industry Collaboration Framework (ICF)

Word count: 1,500

Does your application include industry project partners?

What the assessors are looking for in your response

If industry collaboration does not apply to any of your project partners, or you do not have any project partners, simply add ‘N/A’ into the text box.

If your research project involves collaboration between an academic organisation and an industry or company, you are likely to need to follow the industry collaboration framework and answer this question, check using the ICF decision tree.

The assessors are looking for information relating to the nature, goals and conditions of the collaboration and any restrictions or rights to the project results that could be claimed by the project partner.

By ‘industry or company’ we mean an enterprise that puts goods or services on a market and whose commercial activities are greater than 20% of their overall annual capacity.

Find out more about ICF, including:

  • collaboration agreements
  • definitions of basic or applied research
  • internationally based companies
  • subsidy control
  • Intellectual property (IP) arrangements
  • fully flexible and gated contributions
  • the ICF assessment criteria

In addition to the project partner information completed in the previous section, confirm your answers to the ICF questions in the text box, repeat this process for each ICF project partner:

  1. Name the industry or company project partner considered under ICF.
  2. Indicate whether your application is either basic research or applied research.
  3. Explain why, in the absence of the requested UKRI funding, the collaboration and the planned research could not be undertaken.
  4. State whether your application is under the category of either fully flexible contribution or gated contribution (based on the IP sharing arrangements with the ICF partner).
  5. Outline the pre-existing IP (‘background IP’) that each project partner, including the academic partner, will bring to the collaborative research project and the terms under which project partners may access these assets.
  6. Outline the IP that is expected to be developed during the collaborative research project (‘foreground IP’) and briefly outline how it will be managed, including:
    • which project partners will own this IP
    • what rights project partners will have to use academically generated foreground IP during and after the research project, for internal research and development or for commercial purposes
    • any rights of the academic partner to commercialise the foreground IP, including foreground IP generated by project partners
  7. Outline any restrictions to dissemination of the project results, including the rights of the project partner to:
    • review, approve or delay publications (including the time period associated with such rights)
    • request or require the removal of any information
  8. Declare any conflicts of interest held by the applicants in relation to the project partners and describe how they will be managed.
  9. If applicable, justify collaborating with an overseas industry or company under ICF.

Failure to provide the information requested for industry partners under ICF could result in your application being rejected.

You are recommended to discuss the goals and conditions of any collaboration with an industry or company project partner with your university technology transfer or contracts office before applying.

Trusted Research and Innovation

Word limit: 100

Does the proposed work involve international collaboration in a sensitive research or technology area?

What the assessors are looking for in your response

Demonstrate how your proposed international collaboration relates to Trusted Research and Innovation, including:

  • list the countries your international project co-leads, project partners and visiting researchers, or other collaborators are based in
  • if international collaboration is involved, explain whether this project is relevant to one or more of the 17 areas of the UK National Security and Investment (NSI) Act
  • if one or more of the 17 areas of the UK National Security and Investment (NSI) Act are involved list the areas

If your proposed work does not involve international collaboration, you will be able to indicate this in the Funding Service.

We may contact you following submission of your application to provide additional information about how your proposed project will comply with our approach and expectation towards TR&I, identifying potential risks and the relevant controls you will put in place to help manage these risks.

Facilities

Word limit: 250

Does your proposed research require the support and use of a facility?

What the assessors are looking for in your response

If you will need to use a facility, follow your proposed facility’s normal access request procedures. Ensure you have prior agreement so that if you are offered funding, they will support the use of their facility on your project.

For each requested facility you will need to provide the:

  • name of facility, copied and pasted from the facility information list (DOCX, 35KB)
  • proposed usage or costs, or costs per unit where indicated on the facility information list
  • confirmation you have their agreement where required

Facilities should only be named if they are on the facility information list above. If you will not need to use a facility, you will be able to indicate this in the Funding Service.

Data management and sharing

Word limit: 1,500

How will you manage and share data collected or acquired through the proposed research?

What the assessors are looking for in your response

Provide a data management plan which should clearly detail how you will comply with MRC’s published data management and sharing policies, which includes detailed guidance notes.

Provide your response in the text box following the headings in the MRC data management plan template. You are not required to upload the document to your application.

The length of your plan will vary depending on the type of study being undertaken:

  • population cohorts; longitudinal studies; genetic, omics and imaging data; biobanks, and other collections that are potentially a rich resource for the wider research community: maximum of 1,500 words
  • all other research, less complex, the plan may be as short as 500 words

Ethics and responsible research and innovation (RRI)

Word limit: 500

What are the ethical or RRI implications and issues relating to the proposed work?  If you do not think that the proposed work raises any ethical or RRI issues, explain why.

What the assessors are looking for in your response

Demonstrate that you have identified and evaluated:

  • the relevant ethical or responsible research and innovation considerations
  • how you will manage these considerations

Consider the MRC guidance on ethics and approvals.

You may demonstrate elements of your responses in visual form if relevant. Further details are provided in the Funding Service.

Intellectual property rights (IPR)

Word limit: 700

Provide a brief description of the Intellectual Assets underpinning the proposed work (if any).

Where applicable, describe your future IP management plans to:

  • manage the outputs of the project, including any intellectual assets and intellectual property
  • have freedom to operate
  • protect the foreground IP or market position
  • disseminate and communicate the outputs of your project
What the assessors are looking for in your response

The assessors are looking for you to outline where Intellectual Property (IP) and Freedom to Operate considerations will need to be accounted for (for example: where licenses will need to be obtained).

Note that, at the time of application, or during any subsequent grant, UKRI would not anticipate any business to have exclusive rights to the assets and IP arising from the funded project.

The assessors will judge whether there is an appropriate intellectual property strategy in place to facilitate downstream development, clinical uptake or commercialisation.

Include any IPR if appropriate. If your IPR is a patent, please include the patent numbers along with a summary scope of the claims. We recognise that most applications to Developmental Pathway Gap Fund (DPGF) will not have a patent or other IPR.

Genetic and biological risk

Word limit: 700

Does your proposed research involve any genetic or biological risk?

What the assessors are looking for in your response

In respect of animals, plants or microbes, are you proposing to:

  • use genetic modification as an experimental tool, like studying gene function in a genetically modified organism
  • release genetically modified organisms
  • ultimately develop commercial and industrial genetically modified outcomes

If yes, provide the name of any required approving body and state if approval is already in place. If it is not, provide an indicative timeframe for obtaining the required approval.

Identify the organism or organisms as a plant, animal or microbe and specify the species and which of the three categories the research relates to.

Identify the genetic and biological risks resulting from the proposed research, their implications, and any mitigation you plan on taking. Assessors will want to know you have considered the risks and their implications to justify that any identified risks do not outweigh any benefits of the proposed research.

If this does not apply to your proposed work, you will be able to indicate this in the Funding Service.

Research involving the use of animals

Word limit: 10

Does your proposed research involve the use of vertebrate animals or other organisms covered by the Animals Scientific Procedures Act?

What the assessors are looking for in your response

If you are proposing research that requires using animals, download and complete the Animals Scientific Procedures Act template (DOCX, 74KB), which contains all the questions relating to research using vertebrate animals or other Animals (Scientific Procedures) Act 1986 regulated organisms.

Save it as a PDF. The Funding Service will provide document upload details when you apply. If this does not apply to your proposed work, you will be able to indicate this in the Funding Service.

Conducting research with animals overseas

Word limit: 700

Will any of the proposed animal research be conducted overseas?

What the assessors are looking for in your response

If you are proposing to conduct overseas research, it must be conducted in accordance with welfare standards consistent with those in the UK, as in Responsibility in the use of animals in bioscience research, page 14. Ensure all named applicants in the UK and overseas are aware of this requirement.

If your application proposes animal research to be conducted overseas, you must provide a statement in the text box. Depending on the species involved, you may also need to upload a completed template for each species listed.

Statement

Provide a statement to confirm that:

  • all named applicants are aware of the requirements and have agreed to abide by them
  • this overseas research will be conducted in accordance with welfare standards consistent with the principles of UK legislation
  • the expectation set out in Responsibility in the use of animals in bioscience research will be applied and maintained
  • appropriate national and institutional approvals are in place
Template(s)

Overseas studies proposing to use non-human primates, cats, dogs, equines or pigs will be assessed during NC3Rs review of research applications. Provide the required information by completing the template from the question ‘Research involving the use of animals’.

For studies involving other species, select, download, and complete the relevant Word checklist or checklists from this list:

Explore NC3Rs checklist for the use of animals overseas

Save your completed template as a PDF and upload to the Funding Service. If you use more than one checklist template, consolidate each checklist as a single PDF.

The Funding Service will provide document upload details when you apply.

If conducting research with animals overseas does not apply to your proposed work, you will be able to indicate this in the Funding Service.

Research involving human participation

Word limit: 700

Will the project involve the use of human subjects or their personal information?

What the assessors are looking for in your response

If you are proposing research that requires the involvement of human subjects, provide the name of any required approving body and whether approval is already in place.

Justify the number and the diversity of the participants involved, as well as any procedures.

Provide details of any areas of substantial or moderate severity of impact.

If this does not apply to your proposed work, you will be able to indicate this in the Funding Service.

Research involving human tissues or biological samples

Word limit: 700

Does your proposed research involve the use of human tissues, or biological samples?

What the assessors are looking for in your response

If you are proposing work that involves human tissues or biological samples, provide the name of any required approving body and whether approval is already in place.

Justify the use of human tissue or biological samples specifying the nature and quantity of the material to be used and its source.

If this does not apply to your proposed work, you will be able to indicate this in the Funding Service.

Resources and cost justification

Word limit: 1,200

What will you need to deliver your proposed work and how much will it cost?

What the assessors are looking for in your response

Justify the application’s more costly resources, in particular:

  • project staff
  • significant travel for field work or collaboration
  • any equipment that will cost more than £10,000
  • any consumables beyond typical requirements, or that are required in exceptional quantities
  • all facilities and infrastructure costs
  • all ‘Exceptions’ costs
  • support for public and patient involvement and engagement. Costs for public partnerships including payments to public partners, which are allowed as an ‘Exception’
  • support for preserving, long-term storage, or sharing of data
  • support for international co-leads, demonstrating this is within the 30% costs cap for co-leads from high-income countries, India and China. There is no cap on costs requested for international applicants from DAC list countries
  • NHS research costs, when associated with NHS studies
  • animal costs, such as numbers that need to be bred or maintained and to maintain high welfare standards
  • outsourcing work

Note, regular travel between collaborating organisations and conference costs are not permitted for this funding opportunity and must not be included.

Outsourcing work

If you intend to outsource elements of the proposed work, you must detail:

  • the scope of the outsourced activity being undertaken (and what will be delivered?)
  • the relevance of the outsourced activity
  • why the outsourced activity cannot be undertaken in-house
  • why this provider is most appropriate
  • the cost of any outsourced activity and the tendering process you will follow
  • explain any conflicts of interest (potential or actual) and how they will be managed

Assessors are looking for you to demonstrate how your anticipated costs are needed to deliver your proposed work. Detailed costs or a line-by-line breakdown are not required.

You should ensure your costs are:

  • are comprehensive, appropriate, and justified
  • represent the optimal use of resources to achieve the intended outcomes
  • maximise potential outcomes and impacts

Clinical research using NHS resources

Word limit: 250

Are you applying to do clinical research in the UK?

What the assessors are looking for in your response

Researchers applying to do clinical research in the NHS, public health or social care usually need to complete a Schedule of Events Cost Attribution Tool (SoECAT).

We request the SoECAT because we want to know that you have taken the appropriate steps to request National institute for Health and Care Research (NIHR) support and for the full costs of your research to be attributed, calculated and paid.

We want to see the expected total resources required for your project to consider if these are appropriate.

Enter ‘Yes’ and complete and upload a SoECAT if you are applying for clinical research and:

  • you will carry out your research in the UK
  • your research will use NHS resources
  • the research requires approval by Health Research Authority (England) or its equivalents in Northern Ireland, Scotland or Wales
  • you will need support from the NIHR Research Delivery Network, this may include studies in a social care or public health setting

It is important to complete a SoECAT to be eligible for NIHR support. You must complete a SoECAT even if you do not think your clinical research will involve excess treatment costs (ETCs).

Explore MRC guidance on who needs to complete a SoECAT

How to complete a SoECAT

Explore NIHR SoECAT guidance

These are the steps you need to take:

  1. Contact an attributing the costs of health and social care Research & Development (AcoRD) specialist as early as possible in the application process.
  2. Complete an online SoECAT. Excel versions of the form have been discontinued. If you do not have an account for NIHR’s Central Portfolio Management System (CPMS) you will need create and activate one. See the NIHR user guide for instructions.
  3. Request authorisation of your SoECAT.
  4. Once authorised extract the ‘study information’ and the ‘summary’ page from the ‘Funder Export’, combine them as a single PDF and upload it to your application.

Applications that require a SoECAT but have not uploaded the SoECAT funder export study information and summary may be rejected.

Ensure the AcoRD specialists name and date are included within the uploaded summary page. The SoECAT is invalid without this information.

Contact gapfund@mrc.ukri.org if you have questions about the UKRI aspects of this process or have concerns that your SoECAT may not be authorised in time for the application closing date.

If this does not apply to your proposed work, you will be able to indicate this in the Funding Service.

How we will assess your application

Assessment process

We will assess your application using the following process.

Your application will be assessed by members of the MRC DPFS Panel with additional expertise sourced as necessary.

We will not obtain any external peer review comments as part of the assessment process.

Timescale

We aim to complete the assessment process within 12 weeks of receiving your application.

Feedback

Outcomes will be communicated within ten working days of the panel meeting.

Due to the high volume of applications feedback will not routinely be provided on applications.

Principles of assessment

We support the San Francisco declaration on research assessment and recognise the relationship between research assessment and research integrity.

Find out about the UKRI principles of assessment and decision making.

We reserve the right to modify the assessment process as needed.

Assessment areas

The assessment areas we will use are:

  • background to the application
  • approach (including data management)
  • applicant and team capability to deliver
  • intellectual property rights (IPR)
  • resources and costs requested to do the project
  • ethics and responsible research and innovation (RRI)

Find details of assessment questions and criteria under the ‘Application questions’ heading in the ‘How to apply’ section.

The panel will assess your application based on the following areas:

  • clinical or medical need: whether the need is significant and whether the proposal has an advantage over competing solutions
  • rationale: the strength of the scientific rationale and perceived likelihood that the proposed solution will meet the targeted need
  • deliverability: whether the team has access to the necessary expertise and support to deliver the planned work. Whether the project is designed to generate the right data to progress to the next stage and more substantive funding. Whether the future development plan is realistic, and whether the solution is likely to address the need identified
  • intellectual property: whether there is an appropriate intellectual property strategy in place to facilitate downstream development, clinical uptake or commercialisation

The panel is keen to support high risk projects, as long as the project plan is designed to enable a clear decision on the suitability of the intervention for onward translation, at the end of this phase of funding. Translational projects are inherently risky and therefore a ’failure rate’ of 50% is expected in relation to projects supported.

Projects with no clear and plausible development plan of their proposed route to market or patient benefit after this award are unlikely to be supportable.

Should your application be unsuccessful, you cannot resubmit the same or a similar application to this funding opportunity within 12 months of the original application closing date.

The decisions of the DPFS panel will not be open to appeal.

See the developmental pathway funding scheme panel membership.

Contact details

Get help with your application

If you have a question and the answers aren’t provided on this page

IMPORTANT NOTE: The Helpdesk is committed to helping users of the UK Research and Innovation (UKR) Funding Service as effectively and as quickly as possible. In order to manage cases at peak volume times, the Helpdesk will triage and prioritise those queries with an imminent opportunity deadline or a technical issue. Enquiries raised where information is available on the Funding Finder opportunity page and should be understood early in the application process (for example, regarding eligibility or content/remit of an opportunity) will not constitute a priority case and will be addressed as soon as possible.

Contact details

For help and advice on costings and writing your proposal please contact your research office in the first instance, allowing sufficient time for your organisation’s submission process.

For questions related to this specific funding opportunity please contact gapfund@mrc.ukri.org

For general questions related to MRC funding including our funding opportunities and policy please contact rfpd@mrc.ukri.org

Any queries regarding the system or the submission of applications through the Funding Service should be directed to the helpdesk.

Email: support@funding-service.ukri.org

Phone: 01793 547490

Our phone lines are open:

  • Monday to Thursday 8:30am to 5:00pm
  • Friday 8:30am to 4:30pm

To help us process queries quicker, we request that users highlight the council and opportunity name in the subject title of their email query, include the application reference number, and refrain from contacting more than one mailbox at a time.

For further information on submitting an application read How applicants use the Funding Service

Sensitive information

If you or a core team member need to tell us something you wish to remain confidential, email gapfund@mrc.ukri.org

Include in the subject line: [the funding opportunity title; sensitive information; your Funding Service application number].

Typical examples of confidential information include:

  • individual is unavailable until a certain date (for example due to parental leave)
  • declaration of interest
  • additional information about eligibility to apply that would not be appropriately shared in the ‘Applicant and team capability’ section
  • conflict of interest for UKRI to consider in reviewer or panel participant selection
  • the application is an invited resubmission

For information about how UKRI handles personal data, read UKRI’s privacy notice.

Additional info

Background

This funding opportunity is designed to provide funding to prime the development of a medical prototype, medical product or behavioural intervention. The Developmental Pathway Funding Scheme has identified a gap within the product development lifecycle, between early projects that have established an idea or concept and the projects where significant amounts of preliminary data are required to support requests for larger scale funding.

To mitigate this and support our continuum for funding in product development, a gap fund was proposed to sit beyond the small scale ’pump priming’ MRC Impact Accelerator (IAA) funding and before the substantive Developmental Pathway Funding Scheme awards. It was acknowledged that this scheme needed to be agile, light on bureaucracy, with a quick turnaround and managed by the experts on the Developmental Pathway Funding Scheme to invest in high risk, high reward projects.

The funding can be used to follow on from fundamental science funding across the whole of the UK Research and Innovation (UKRI) remit including:

  • MRC boards
  • MRC strategic funding opportunities
  • MRC/AstraZeneca Centre for Lead Discovery
  • MRC/UCB Antibody Discovery Initiative
  • any Research Council funding
  • other funding, including non-UKRI

This funding opportunity will be embedded within the MRC Translational funding opportunities (MRC Impact Accelerator Accounts, MRC Developmental Pathway Funding Scheme and Experimental Medicine).

This funding opportunity should not be used to support projects that are within scope for MRC IAA, except in relation to projects that are conducted solely at a research institution that does not hold an MRC IAA.

Projects will not be milestoned – a light touch post award process will be put in place with progress reports requested after 12 months and at the end of the project.

Requests for change, relating to unforeseen scientific changes will not be considered in relation to these rewards. Requests related to maternity, paternity, adoption, parental or sick leave will be allowable under standard grant conditions.

Resources

You may find the following organisations and resources useful when preparing an application:

The MRC Regulatory Support Centre acts as a hub for advice and resources around research using human participants, their tissues, or data.

Applicants considering a drug repurposing project may wish to explore the Repurposing Medicines Toolkit, developed by MRC and LifeArc.

Applicants considering the development of clinical tests may wish to explore the supplementary applicant guidance prepared by MRC.

The NHS Innovation Service acts as an information gateway to support people developing new innovative products, services or initiatives in healthcare.

The MRC-LifeArc Innovation Hubs for Gene Therapies Network supports academic-led early phase clinical development of gene therapies through manufacturing of good manufacturing practice viral vector, translational and regulatory support, and manufacturing development support ahead of clinical development.

The Nucleic Acid Therapy Accelerator (NATA) provides dedicated research capability, infrastructure and support to enable advances in the development of nucleic acid therapeutics.

Research and innovation impact

Impact can be defined as the long-term intended or unintended effect research and innovation has on society, economy and the environment; to individuals, organisations, and the wider global population.

Additional disability and accessibility adjustments

UKRI can offer disability and accessibility support for UKRI applicants and grant holders during the application and assessment process if required.

Research disruption due to COVID-19

We recognise that the COVID-19 pandemic has caused major interruptions and disruptions across our communities. We are committed to ensuring that individual applicants and their wider team, including partners and networks, are not penalised for any disruption to their career, such as:

  • breaks and delays
  • disruptive working patterns and conditions
  • the loss of ongoing work
  • role changes that may have been caused by the pandemic

Reviewers and panel members will be advised to consider the unequal impacts that COVID-19 related disruption might have had on the capability to deliver and career development of those individuals included in the application. They will be asked to consider the capability of the applicant and their wider team to deliver the research they are proposing.

Where disruptions have occurred, you can highlight this within your application if you wish, but there is no requirement to detail the specific circumstances that caused the disruption.

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