Funding opportunity

Funding opportunity: Funding for early stage development of new healthcare interventions

Start application

Apply for funding 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.

The idea for a new product that can improve human health should have already been conceived and supported by other funding. This should be utilised to produce the critical preliminary data needed to support the onward development of the product.

The Developmental Pathway Gap Fund (DPGF) sits beyond the smaller Impact Accelerator Account (IAA) funding and before the substantive and longer Developmental Pathway Funding Scheme (DPFS) funding.

This is an ongoing funding opportunity. Application rounds close every March, July and November.

The start application link will appear when the opportunity opens 3 January 2024 9:00am.

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 a researcher 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

International co-leads

You can include international applicants as project co-leads if they provide expertise not available in the UK and make a major intellectual contribution to the design or conduct of the project. You must justify in your application, why their expertise is required, see ‘Applicant and team capability to deliver’ section.

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 proposals 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.

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 the earlier stage. Applicants should highlight within the application that they are applying for an IAA-like project.

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 of toxicology studies (supported by the MRC Developmental Pathway Funding Scheme)
  • early-phase clinical trials (supported by the MRC Developmental Pathway Funding Scheme)
  • late-phase clinical trials (supported by the National Institute for Health and Care Research (NIHR) Efficay 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

We will fund projects lasting 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 100% full economic cost (FEC) of your project can be between £50,000 and £300,000.

We will provide funding at 80% of the FEC.

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 discouraged from these awards)
  • 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

Project partners

You may include third party 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 third party individual or organisation named as project partner must provide a statement of support (letter or email).

You should not include any letters or emails of support from organisations that will not directly contribute to your project as a third party project partner or are simply expressing supportive opinions.

You must not include any additional documents, email communications or any other type of information we have not requested.

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

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

The individual named as the contact for the project partner organisation cannot also be a named applicant (such as project lead, co-lead or any other named member of staff). This includes the organisation associated with the named applicant or based within other departments (when the organisation is already included within the application).

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.

International collaboration

UK Research and Innovation (UKRI) is committed to 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.

How to apply

We are running this funding opportunity on the new UK Research and Innovation (UKRI) Funding Service. 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.

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

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.

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.
  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. If using visual elements, you must:

  • 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)
  • files must be smaller than 8MB 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:

Deadline

We must receive your application by 13 March 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 may make this summary publicly available on external-facing websites, so 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))
  • researcher co-lead (RcL)
  • specialist
  • grant manager
  • professional enabling staff
  • research and innovation associate
  • technician
  • visiting researcher

Only list one individual as project lead.

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

Application questions

Background to application

Word limit: 500

What is the background to this application and evidence to support the proposed solution?

What the assessors are looking for in your response

Ensure that you provide:

  • a brief overview of the background of your application
  • information related to your previously funded applications and funders, if any, that have enabled and informed the work proposed in the application, specifying any previous UKRI application references

Additionally, you should look to:

  • identify if your application is a re-submission, including any invitations from MRC permitting your re-submission and how the proposed work has developed
  • 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 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: 1,500

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)
  • summarises the previous work and describes how this will be built upon and progressed (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 key gap that the project’s primary objective is seeking to address
  • 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 project plan to support your application and information on how the proposed work has a reliable and robust methodology and experimental design.

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 proposal
  • 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 of 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, section 2.2.3.5 Reproducibility and statistical design, 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 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.

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

Applicant and team capability to deliver

Word limit: 1,500

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 service.

The word count for this section is 1,500 words: 1,000 words to be used for R4RI modules 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.

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

For full details, see Eligibility as an individual.

References

Word limit: 1,000

List the references you have used to support your application.

What the assessors are looking for in your response

Include all references in this section, not in the rest of the application questions.

You should not include any other information in this section.

We advise you not to include hyperlinks, as assessors are not obliged to access the information they lead to or consider it in their assessment of your application.

If linking to web resources, to maintain the information’s integrity, include persistent identifiers (such as digital object identifiers) where possible.

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

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, such as an industrial partner, 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.

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 statement (see next section ‘Project partners: letters or emails of support’).

The individual (including their organisation) named as the project partner contact, cannot also be included within your application as an applicant, such as project lead or any other core team role.

You cannot include a different department (based within the same organisation as a member of your core team) 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 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.

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.

Important information when completing the project partners section within the Funding Service

When completing your application in the Funding Service, if you discover that you have entered project partner information incorrectly and you have saved the entry, you should remove the specific project partner record and re-add it with the correct information.

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 partner’ section.

If you do not have any project partners, you will be able to indicate this in the Funding Service.

What supporting statements we are looking for

Important note: MRC is only looking for you to provide a project partner letter or email of support from the following:

  • a third party individual
  • a third party organisation

You must ensure that any third party project partner providing a supporting document, are also added to the ‘Project partners’ section.

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

What supporting statements we are not looking for

MRC is not looking for you to provide any supporting emails or letters of support related to any individual or organisation already included within your application (this includes other departments within the same organisation). Any individual or organisation included in your application with a role as listed below, cannot also be a project partner, such as:

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

Check the opportunity specific roles available in the core team section for the definitive list.

Do not include any additional documents, email communications or any other type of information we have not requested, including supporting statements (letters or emails), simply expressing supportive opinions (we only expect to see emails or letters of support from 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 third party project partner supporting letter or email you provide, should:

  • be no more than two A4 pages (only one email or letter of support is permitted for each project partner)
  • 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 separate ‘project partners’ application 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 email or letter 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 email or letter 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.

Industry collaboration framework (ICF)

Word limit: 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.

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.

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.

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 the 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.

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

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 following the MRC data management plan template.

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, if 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 service.

Intellectual property rights (IPR)

Word limit: 500

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

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.

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
Templates

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:

Save your completed template as a PDF and upload to the Funding service. If you use more than one checklist template, save it 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 (but not regular travel between collaborating organisations or to conferences)
  • 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 resources that have been costed as ‘Exceptions’
  • support for:
    • public and patient involvement and engagement
    • preserving, long-term storage, or sharing of data
    • international co-leads, demonstrating this is within the 30% costs cap for co-leads from developed countries, India and China. There is no cap on costs requested for international applicants from DAC list countries
  • NHS research costs, when they are associated with NHS studies
  • animal costs, such as numbers that need to be bred or maintained and to maintain high welfare standards
  • any work to be outsourced

For outsourcing work; If you intend to outsource elements of the proposed work, provide the following information:

  • the scope of the outsourced activity (what is being undertaken and what will be delivered?)
  • the relevance of the outsourced activity to the application
  • why the outsourced activity cannot be undertaken in-house
  • why this provider is the most appropriate
  • the cost(s) of the outsourced activity and the tendering process that will be followed
  • explain any conflicts of interest (potential or actual) between parties and how these will be managed

Assessors are not looking for a detailed, line-by-line breakdown of costs. Overall, they want you to demonstrate how the resources you anticipate needing for your proposed work:

  • 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

Will your research involve participants from the NHS or Health and Social Care duty of care?

What the assessors are looking for in your response

If not, enter ‘N/A’ into the text box

Researchers applying for clinical research in the NHS, public health or social care need to complete a Schedule of Events Cost Attribution Tool (SoECAT) to be eligible for the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio. This is the route through which support and excess treatment costs are provided in England.

You must answer ‘Yes’ and complete and upload a SoECAT if you are applying for clinical research funding, and:

  • you will carry out your research in the UK
  • it is intended for the NIHR CRN portfolio; this may include studies in a social care or public health setting
  • the research requires approval by Health Research Authority (England) or its equivalents in Northern Ireland, Scotland or Wales
  • your research will use NHS resources

You must complete a SoECAT even if you do not think your clinical research will involve excess treatment costs (ETCs).

See MRC guidance 3.5.1 on who needs to complete a SoECAT.

If you are applying for clinical research in the NHS, public health or social care and do not think you need to complete a SoECAT, answer ‘Yes’ and explain why a SoECAT is not necessary.

We want to know that you have taken the appropriate steps 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, such as Excess Treatment Costs (ETCs), to consider if these are appropriate.

How to complete a SoECAT

SoECAT guidance can be found on the NIHR website.

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 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 attached the SoECAT funder export study information and summary may be rejected.

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 deadline.

How we will assess your application

Assessment process

We will assess your application using the following process.

Your application will be assessed by the MRC Developmental Pathway Funding Scheme (DPFS) panel of experts.

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 of the project
  • approach of the project
  • data management
  • Intellectual property rights (IPR)
  • capability of the applicant or applicants and the project team to deliver the project
  • resources requested to do the project
  • ethical and responsible research and innovation considerations of the project

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 (UKRI) 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.

Find out more information on submitting an application.

Sensitive information

If you or a core team member need to tell us something you wish to remain confidential, please contact 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

The 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
  • Biotechnology and Biological Research Council boards and panels
  • Engineering and Physical Sciences Research Council boards and panels
  • Science and Technology Facilities Council boards and panels
  • Natural Environment Research Council boards and panels
  • other funding, including non-UKRI

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

The 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 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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