Funding opportunity

Funding opportunity: UKRI translation: MRC proof of concept: stage two

This funding opportunity was previously titled ‘Developmental pathway funding scheme: stage two’.

You must be invited to apply for stage two of this funding opportunity.

Apply for funding to develop and test novel therapeutics, medical devices, diagnostics and other interventions across any stage of the developmental pathway, from prototype development, through pre-clinical refinement, to early-phase clinical studies (up to phase 2a).

There is no funding limit but requested costs should be appropriate to the project. We usually fund 80% of a project’s full economic cost (FEC).

Who can apply

You can only apply for this funding opportunity if we have invited you to do so following a successful stage one application.

This funding opportunity is open to organisations with standard eligibility. Check if your organisation is eligible.

Who is eligible to apply

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

  • show that you will direct the project and be actively engaged in the work
  • be part of a team that submitted a Developmental Pathway Funding Scheme (DPFS, now titled ‘MRC Proof of Concept) stage one application and, after successful assessment, have been invited to submit a stage two application for this funding opportunity. Additional team applicants can be included that were not in the stage one application
  • or, be part of a team that have been invited to submit a DPFS (now titled ‘MRC Proof of Concept) stage two application as part of a panel-approved resubmission

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

Resubmissions

We will not accept uninvited resubmission of applications that were submitted after 1 April 2026 to MRC, the rest of UK Research and Innovation (UKRI) or any other funder. An uninvited resubmission is an application that was previously unsuccessful and has been submitted again without being invited by MRC. This includes applications that are unchanged, minimally revised, or substantially the same as the original submission.

You should contact us if you are unsure whether your application is a resubmission. Find contacts in the ‘Contact details’ section.

International researchers

As MRC is a lead funder for this opportunity, international researchers can apply as ‘project co-lead (international)’.

Project co-leads (international) make a major intellectual contribution to the design or conduct of the project. Their contribution and added value to the research should be clearly explained and justified in the application, see ‘Applicant and team capability to deliver’.

Read about UKRI project co-lead (international) eligibility for more details. Contact us if you are uncertain about eligibility.

You should include all other international collaborators as project partners.

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

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

What we're looking for

Demand management

Demand management is not being applied to this funding opportunity.

Scope

You can apply for academically-led translational projects that aim to either:

  • improve prevention, diagnosis, prognosis or treatment of significant health needs
  • develop research tools that increase the efficiency of developing interventions
    All human diseases and medical interventions are eligible for support, both in the context of UK healthcare and addressing global health issues.

Your project can start and finish at any stage on the developmental pathway from early prototype development, through pre-clinical refinement and testing, to early-phase clinical studies and trials (up to phase 2a). You can submit follow-on proposals where you can justify the need for continued support.

Activities we support

You can apply for funding for work on novel:

  • candidate therapeutic entities (for example, drug discovery)
  • vaccines for infectious or non-infectious disease
  • biologics (antibodies, peptides, proteins)
  • advanced therapeutics (for example, gene therapy and cell therapy)
  • regenerative medicine approaches
  • repurposing clinical studies or using existing therapies for new indications
  • medical devices
  • digital healthcare and app development
  • diagnostics (including biomarker validation and development of clinical decision-making tools)
  • medical imaging technology
  • surgical techniques or tools
  • behavioural and psychological interventions
  • radiotherapy and radiation protocols
  • interventions that benefit health in low and middle-income countries

Activities we do not support

This funding opportunity will not support:

  • fundamental or investigative research not linked to a development plan, supported by the MRC science areas such as MRC: research grant: applicant-led
  • studies where the main aim is to investigate disease mechanism (supported by the MRC Experimental Medicine Panel)
  • technology development not aligned to a medical or clinical developmental plan, likely Biotechnology and Biological Sciences Research Council (BBSRC) or Engineering and Physical Sciences Research Council (EPSRC) remit
  • late-phase clinical trials (supported by the National Institute for Health and Care Research (NIHR) efficacy and mechanism evaluation, health technology assessment, and global health research programmes)
  • development of technologies or interventions that aim to improve health service delivery rather than meeting a specific clinical need
  • development of population-level and societal solutions to healthcare challenges

Learn about:

Duration

There is no limit to the duration of your project. You should justify the timescale of the project in the context of the proposed work.

Award start date

Projects should start one to six months after the funding decision date. Applications following on from active awards should consider the current status of those projects when submitting a stage two application.

Funding available

There is no limit to the amount of funding you can apply for. You should justify the resources needed in the context of the proposed work.

We will fund 80% of the full economic cost and 100% of permitted exceptions.

Find out more about full economic costing.

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
  • data preservation, data sharing and dissemination costs
  • estates and indirect costs
  • public partnerships and related activities, including payments to public contributors

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

The total of such costs requested for international applicants from high-income countries (HIC) (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.

See more information on international costs and what we will and will not fund 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

Collaborations

We encourage working with charities or industry partners where these partnerships can add value to the project.

Collaborators may add value by giving access to:

  • expertise
  • technologies
  • reagents
  • funding

Please note that collaboration is not a prerequisite for application. You should make a clear case for the MRC Proof of Concept award being academic-led and requiring MRC funding to support the work proposed.

Be clear about any conflicts of interest and how they will be managed through the conflict of interest policies at the project lead’s research organisation.

Project partner

A project partner is a collaborating organisation in the UK or overseas, including partners based in the EU, who will have an integral role in the proposed research.

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 project partner

Any individual included in your application with a core team 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.

See further guidance and information about TR&I, including where applicants can find additional support.

How to apply

We are running this funding opportunity on the 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.

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

You can only apply for this funding opportunity if we have invited you to do so following a successful stage one application. The start application link will be provided via email.

  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.
  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.

Please be aware that research office and finance teams undertake checks on hosting arrangements and financial eligibility. The ultimate responsibility for ensuring compliance with all opportunity requirements lies with the applicant.

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

When including images, you must:

  • provide a descriptive caption or legend for each image immediately underneath it in the text box (this must be outside the image and counts towards your word limit)
  • insert each new image on a new line
  • use files smaller than 5MB and in JPEG, JPG, JPE, JFI, JIF, JFIF, PNG, GIF, BMP or WEBP format

Images should only be used to convey important visual information that cannot easily be put into words. The following are not permitted, and your application will be rejected if you include:

  • sentences or paragraphs of text
  • tables
  • excessive quantities of images

A few words are permitted where the image would lack clarity without the contextual words, such as a diagram, where text labels are required for an axis or graph column.

For more guidance on the Funding Service, see:

References

References should be included within the word count of the appropriate question section. You should use your discretion when including references and prioritise those most pertinent to the application.

Hyperlinks can be used in reference information. When including references, you should consider how your references will be viewed and used by the assessors, ensuring that:

  • references are easily identifiable by the assessors
  • references are formatted as appropriate to your research
  • persistent identifiers are used where possible

General use of hyperlinks

Applications should be self-contained. You should only use hyperlinks to link directly to reference information. You must not include links to web resources to extend your application. Assessors are not required to access links to conduct assessment or recommend a funding decision.

Generative artificial intelligence (AI)

Use of generative AI tools to prepare funding applications is permitted, however, caution should be applied.

For more information see our policy on the use of generative AI in application and assessment.

Deadline

MRC must receive your application by 4 November 2026 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 this funding opportunity, your application cannot be changed, and submitted applications will not be amended. 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.

Sensitive information

If you or a core team member need to tell us something you wish to remain confidential, email dpfsanddcs@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.

Institutional matched funding

There is no requirement for matched funding from the institutions hosting the project lead, project co-leads or other staff employed on the application, beyond the standard 20% FEC. Expert reviewers and panels assessing UKRI funding applications must not consider levels of institutional matched funding as a factor on which to base recommendations. Direct and in-kind contributions from third party project partners are encouraged.

This policy does not remove the need for support from host organisations who must provide the necessary research environment and infrastructure for award-specific activities funded by UKRI. For example, research facilities, training and development of staff.

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. UKRI has introduced a new addition to the ‘Specialist’ role type. Public contributors such as people with lived experience can now be added to an application.

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

Application questions

Related applications

Word limit: 2,200

Provide a response to feedback from your stage one Developmental Pathway Funding Scheme (DPFS) application or previous stage two DPFS application. You should include the feedback as part of your response. This counts towards the word limit.

What the assessors are looking for in your response

Ensure you describe:

  • how this application differs from the previous application
  • how previous feedback has been considered and addressed

Please identify, if applicable, if your application is a resubmission to DPFS, including any invitations from us permitting your resubmission and previous reference number.

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: 1,500

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 clinical or translational bottleneck
  • the competing solutions and their status, including whether similar or complementary research and development is being undertaken elsewhere
  • the key competitive advantages of your proposed solution
  • the potential market for your proposed solution. Quantify this in terms of the target product profile, patient numbers and financial parameters

Building on your stage one application, you should also describe in detail:

  • the timeliness of your approach
  • the end users of your proposed solution, such as clinicians, primary care staff, technical specialists
  • any engagement with end users, patients, carers or the wider public in the development of the project
  • any further needs that could be addressed by your proposed solution or components of it, such as use as a platform technology

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

Scientific background and current stage of development

Word limit: 2,500

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 detailed description of the current stage of development
  • an overview of the rationale and scientific background of your application
  • updated information about your previous or current funding (if applicable) that has enabled and informed the proposed work, include any previous UKRI grant references. If you will have any funding concurrent to this project, explain any overlap and how that funding will support the proposed work
  • in the case of applications involving institutes, units or centres with existing core funding, including those funded by UKRI and National Institute for Health and Care Research (NIHR) such as Biomedical Research Centres (BRCs), describe how the proposed work and resources requested builds on, but is distinct from, core funded programmes of research

In this section, you must also provide supporting data (including figures, tables and images where relevant) to demonstrate the current development stage of your project and proof-of-concept to support your application. Further details are provided in the Funding Service.

References may be included within this section.

Small molecule supplementary information

Word limit: 1,500

If you are requesting funding for a hit to lead, lead optimisation or candidate selection project, please provide structures.

What the assessors are looking for in your response

If your application is not about hit-to-lead and lead optimisation, enter ‘N/A’ in the text box, mark this section as complete and move to the next question.

Small molecule supplementary information

You will be asked to provide Chemotype and or series one and two information related to:

  • physicochemical properties
  • in vitro biological activity
  • in vitro DMPK assays
  • in vivo DMPK assays
  • toxicology and safety Assays
  • in vivo date (if available)

Additional guidance will be provided on the Funding Service on how to provide this information, including the required format.

Using the following headings, ensure that you provide target product profile (TPP) or key target compound parameters of the proposed investigational new drug (IND):

  • target name
  • mechanism of action, such as agonist, antagonist
  • route of administration, such as oral, IV, topical
  • duration of treatment, such as acute or chronic
  • dosage regimen, such as twice daily
Structure and data

You should provide structures for the most promising chemical series being actively developed. Failure to include chemical structures may negatively impact the ability to assess the suitability or strengths of your proposed chemistry plan. Data are requested for any available assays for the lead molecule shown and the range seen within the chemical series, including (but not limited to):

  • biological assays
  • physicochemical properties
  • liabilities and development risks for up to two chemotypes or chemical series
Project tractability

You should:

  • summarise the main structure activity or property relationships for each chemical series
  • highlight the key challenges to optimisation of the series towards the TPP and outline how these will be addressed
  • describe the biological assays and models to be used in the project including their duration and throughput where relevant
  • explain how risk associated with the translation between in vivo assays, in vivo models, and activity in humans will be minimised

Development plan and route to patient benefit

Word limit: 1,000

What is the proposed approach for further development, and how will the project progress the innovation or technology towards achieving market or health or patient benefits?

What the assessors are looking for in your response

Using the following headings, ensure you describe in detail:

Current development plan

You should describe:

  • the project’s primary objectives
  • the project endpoint that would indicate that there is a reasonable chance of attracting onward investment
  • the expertise or any consultancy required to deliver the proposed work
  • how the proposed work will enable development of the innovation or technology
  • how the proposed work will inform or deploy the innovation or technology using the most appropriate route to market or patient benefit
Exit strategy

You should describe:

  • what further support you may need, following this funding, to deliver your product or technology, such as access to further funding, networks, partnerships, private investment and skills
  • the criteria that would need to be met to access the further support
  • if you are ultimately seeking to develop a commercial product, how the market value will be realised such as through business development plans
  • any engagement planned or that has taken place with potential downstream funders, partners, regulators or commercialisation entities, outlining who they are and the status of discussions. You should justify your engagement plans, such as approaches and timing within the project
  • the plans and strategy for further development, outlining the planned route to achieving patient benefits following the end of your project

Approach

Word limit: 3,500

How are you going to deliver your proposed work?

What the assessors are looking for in your response

We suggest you structure your response using the following headings, with approximate word counts for each:

  • project plan: 1,500 words
  • methodology and experimental design: 750 words
  • risk management: 450 words
  • environment, infrastructure and equipment: 450 words
  • references: 350 words

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

Project plan

Provide a detailed project workplan which should include:

  • project specific deliverables
  • a minimum of two key progression milestones (one being the project end)
  • the project’s starting point and approaches proposed to deliver the planned objectives
  • the resourcing and time necessary to deliver the proposed work, and justification that these will be sufficient
  • a description of any contingency planning that has been factored in
  • any regulatory approvals required. If you have consulted with the relevant regulatory body or experts, please summarise the outcome of the discussions

You should also include the project management requirements, including the commitment and involvement from your:

  • research office
  • translational research office, your technology transfer office or both (include key contacts and their positions)

To support your project plan, you must also embed a legible Gantt chart in the text box that includes:

  • project tasks with, where relevant, the party responsible for delivering the task and dependency between tasks
  • at least two milestones, which are major, specifically timed decision points that are defined by SMART (specific, measurable, achievable, relevant and timely) success criteria and detailed, robust ‘go or no-go’ criteria

You should check the readability of your embedded ‘Gantt chart’ using the ‘read view’ on the Funding Service. Sizes of images can be adjusted when editing within the text box.

Methodology and experimental design

As part of your methodology and experimental design, ensure that you describe:

  • the use of animals or patients, including justification for why particular animal models or clinical populations have been chosen, following the MRC embedding diversity in research design policy
  • if applicable, show how you will use males and females in research involving animals and tissues and cells. If you are not proposing to do this, a strong justification is required
  • 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
  • for clinical studies, the recruitment and retention strategy, and the evidence that this will be feasible
  • explain and justify the inclusion of public partnerships (if applicable) and the added value these offer

Refer to the MRC guidance for applicants, for further information.

Use the ‘Animal Involvement and “3Rs”’ 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.

Risk management

Describe the key risks to the project and your risk management plan, including:

  • how likely the risks are to occur
  • what their impact would be on the success and deliverability of the project
  • how these risks will be managed, by whom and related escalation or mitigations procedures

You may use a risk table if preferred.

Environment, infrastructure and equipment

Describe 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.

Demonstrate access to the appropriate services, facilities, infrastructure, or equipment to deliver the proposed work, including:

  • specialist equipment or infrastructure required to deliver the project objectives
  • proposed use of existing joint research facilities
  • proposed use of existing clinical infrastructure, for example the Experimental Cancer Medicine Centre Network, NIHR Biomedical Research Centres, NIHR clinical research facilities, patient cohorts
  • if not already in place, explain how you will ensure this infrastructure is accessible by the project start date

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.

Reproducibility and statistical design

Word limit: 500

How will you ensure your proposed work is reliable, robust and reproducible?

What assessors are looking for in your response

Information about reproducibility and how you will ensure reliability and robustness of your proposed work, such as further details of statistical analyses, methodology and experimental design, not provided in your approach.

We expect you to seek professional statistical or other relevant advice in preparing your response, which should include, as appropriate:

  • sample and effect sizes
  • planned statistical analyses
  • models chosen (for example animal model, cell line)
  • potential sources of bias and how these will be mitigated during analysis
  • how your approach to addressing diversity is reflected in the experimental design and analyses

Ensure you justify your proposed samples and effect sizes, statistical analysis plan and any assumptions used.

Refer to the MRC guidance for applicants, for further information, examples and online tools.

If your proposed work involves animals, and you provide information on animal sample sizes and statistical analyses here, you should not duplicate it in the ‘Animal Involvement and “3Rs”’ section. Use the ‘Animal Involvement and “3Rs”’ section to provide information on the rationale for using animals, choice of species, welfare and procedure severity.

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

The length of your response will vary depending on the type of project, you may not need to use 500 words.

Milestones

Word limit: 1,500

Provide details of your project milestones.

What the assessors are looking for in your response

Provide at least two key progression milestones for your project (one of which should be the project end), that:

  • delineate the proposed work into costed project phases with clear ‘go or no-go’ decision points
  • provides the success criteria that will be used for each milestone, with target and acceptable thresholds

You may add as many milestones as needed for your project, but ensure that these are consecutive rather than concurrent, and reflect key project progression decision points. Proof of concept projects typically have two to four milestones (including the project end).

Milestones must be SMART, that is specific, measurable, achievable, relevant, and time-framed.

They should:

  • detail robust ‘go or no-go’ criteria (failure to meet these will result in early termination of the project)
  • be structured so that the critical questions are addressed as early as possible in the plan

Success criteria should be based on project outputs that, at the given point, need to be achieved in order to justify further continuation of the project. Success criteria should align to project aims and objectives. Success criteria for the final milestone should reflect outcomes representing successful completion of the project.

For each success criterion, specify:

  • a quantified target value that you aim to achieve
  • a quantified acceptable value, which, if achieved, would support project progression

A brief justification should be provided for the criteria and values selected, explaining why they are suitable for assessing progress at this point in the project. Note that target and acceptable values must be achieved at the same timepoint and that milestones must be sequential.

For clinical studies, this should include a summary of:

  • study design
  • study participants
  • study endpoints
  • dose (when applicable)
  • analysis plans

Do not include project management meetings or other process-related tasks as milestone success criteria.

Additional guidance will be provided on the Funding Service on how to complete this section, including the required format.

For each milestone, you will be asked to provide the following details:

  • duration (in months) from project start and from the previous milestone (not applicable for the first milestone, milestone one)
  • milestone full economic costing (FEC) and cumulative FEC from project start
  • likelihood of meeting the milestone’s criteria
  • objectives
  • measurable success criteria with target and minimum acceptable values for each criterion, along with a justification for these choices

Projects involving advanced manufacturing of cell and gene therapy products

Word limit: 1,000

If you are requesting funding for Good Practice (GxP) manufacture of cell and gene therapy products, provide details and justify your approach. The information provided should be appropriate to the development stage of your intervention.

What the assessors are looking for in your response

GxP describes the quality guidelines and standards mandated by regulators to ensure that medicines are safe, effective, and consistent in quality. GxP encompasses several sets of regulations, the most common being:

  • Good Laboratory Practice (GLP), governing non-clinical laboratory studies such as stability testing
  • Good Manufacturing Practice (GMP), as the primary, mandatory standard for production for use in clinical studies

If your application does not involve GxP manufacturing of cell and gene therapy products, enter ‘N/A’ in the text box, mark this section as complete and move to the next question.

Contact us if you are unsure if this question is relevant to your application. Find contacts in the ‘Contact details’ section.

Describe the scale, characteristics, quality standard (such as GLP and or GMP), and intended use (for example, for GLP safety and toxicology studies) of all viral vector and or cell therapy batches to be manufactured. You should:

  • provide information on the target quantity and quality of product to be manufactured including, if relevant: titre and fill volume(s), empty to full ratio, number and viability of cells, phenotype and potency
  • detail your planned or predicted dose requirements and describe how this informs the proposed scale of manufacture
  • provide details of the manufacturer(s), if known, and summarise their expertise and experience in manufacturing the product at the relevant scale and quality. You should also provide information on capacity and anticipated timelines for manufacture
  • provide an assessment of the potential manufacturing risks and propose mitigation strategies

Describe how batches will be validated, tested or both. You should:

  • confirm whether appropriate assays have already been developed. If assays are not yet developed, you should describe when these assays will be developed and by whom
  • confirm where validation will be carried out
  • include, if relevant, any recommendations from regulatory agencies. You may upload up to five pages of correspondence with regulators to this section

Applicant and team capability to deliver

Word limit: 2,000

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 limit for this section is 2,000 words: 1,500 words to be used for Résumé for Research and Innovation (R4RI) modules (including references) and, if necessary, a further 500 words for Additions.

Use the 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, this may include your previous funding and key outputs such as publications
  • 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, including public partnerships
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.

The roles in funding applications policy has descriptions of the different project roles.

Intellectual property (IP) management and dissemination of project outcomes

Word limit: 1,500

Attachment: International Search Report (five pages)

What IP will be generated and how would it be managed during the project? Do you have freedom-to-operate to carry out the project and any downstream work?

What the assessors are looking for in your response

IP is a collective term for all intangible assets such as data, clinical trial results, software, know-how, materials, inventions, methods, designs and the associated intellectual property rights (including patents, copyright and trademarks).

The generation of protectable intellectual property is not an essential requirement for MRC Proof of Concept. Projects that will not generate patentable materials but that will nevertheless have the potential to provide health benefits are accepted on an equal basis. However, ownership and management of IP must be consistent with our funding requirements.

Projects with no plausible route to exploitation and ultimate health benefit or impact are extremely unlikely to be supportable.

Using the following headings where applicable:

IP generation and management

You should:

  • describe any new intellectual property or knowledge that the project is expected to generate
  • explain how any intellectual assets generated will be managed throughout the project to enable further development and ensure future success
  • etail the organisations or individuals who will own any arising IP and any live, pending or envisioned agreements governing ownership or exploitation of that IP
Prior art

You should:

  • list all existing technologies and IP that will be developed or utilised as part of your MRC Proof of Concept project. Please include patent numbers, patent claim coverage, ownership and status where relevant
  • provide a summary of the most relevant prior art, with details on the database searched, dates of the searches and the search terms. You may upload a summary of international search report (up to five A4 pages) to support your application
  • describe the potential impact of prior art on the strategy for protection of IP, including any disclosure of background IP by the applicants or a third party
Freedom to operate

You should:

  • explain if the applicants have freedom to operate for this project, for future development work, or for clinical use. What IP does the project need access to for the project and for future development
  • if access to background IP is required, detail the organisations or individuals that hold the relevant background IP rights. If this background IP is held by a third party (or a non-academic applicant), has access been agreed? If not, why do you believe you will be able to access the required IP on reasonable terms
Conflict of interest and management

You should:

  • explain if any of the academic applicants have an interest in the commercial owners of background technologies or IP, such as shareholding options or consultancy fee
  • if there are material or potential conflicts of interest, explain the nature of these and how they would be managed during the project and during decision-making regarding IP

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 person or organisation who will have an integral role in your proposed research. This may include direct contributions for example cash, donated equipment and resources, or staff seconded to the project, or indirect and in-kind contributions for example use of project partner’s equipment, datasets, or facilities. Project partners may be in industry, academia, third sector or government organisations in the UK or overseas, including partners based in the EU.

A project partner is not anyone in your core team or anyone from your organisation or any of the other organisations represented by core team members.

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.

Important information

If you are adding a project partner to this section, you must ensure they provide you with a letter or email of support and you should upload it to ‘Project partners: letters or emails of support’.

If your project partners are from industry or a company, you must also complete the ‘Industry Collaboration Framework (ICF)’ section.

Project partners responsible for carrying out animal work

If the project partner is responsible for conducting animal work or providing animals or animal tissue samples, you must ensure that you complete and upload the appropriate forms under the ‘Animal Involvement and “3Rs”’ section (if applicable).

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

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

We are looking for you to provide letters or emails of support from all your identified project partners.

What we are not looking for

We don’t want any other letters (or emails) of support, from people who are not your identified project partners, such as those simply expressing general support for your project. If these are included by you, they will be ignored by us and will not be used in the assessment process.

Important information

You should only provide letters or emails of support from people you have identified in the project partner section of your application, who will have an integral role in your proposed research.

What each project partner letter or email of support must include

Each project partner letter or email you provide should:

  • include the name of the project partner organisation and contact information
  • explain the project partners’ commitment to the project
  • explain the value, relevance, and possible benefits of the proposed work, to them
  • describe any additional value they will bring to the project
  • not exceed two sides of A4 per project partner

Project partner letters and emails of support are not required to be on headed paper or include handwritten signatures (electronic signatures are acceptable).
The Funding Service will provide document upload details when you apply.

Project partners from industry or a company

Industry or company project partners are required to download and complete the industry or company letter of support template. If your project partner(s) are from industry or a company, then you must indicate if you intend to apply under the ‘Industry Collaboration Framework (ICF)’ by adding “ICF” to your application title. You must also complete the ‘Industry Collaboration Framework (ICF)’ section. Find out more about ICF.

Project partners responsible for recruiting research participants or providing human tissue or samples

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)
Agreement with your project partners

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 limit: 1,500

Does your application include collaboration with industry or company project partners?

What the assessors are looking for in your response

The assessors are looking for you to confirm if your proposed work involves collaboration with an industry or company project partner. If it does, you will need to follow the MRC industry collaboration framework (ICF).

By ‘industry or company’ we mean an enterprise that puts or has intention to put goods or services on a market.

For guidance to assist your decision if your proposed work requires you to follow ICF, you should explore the ICF decision tree and find out more about ICF which includes:

  • 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

Enter ‘Yes’ in the text box if you have industry or company project partners and you are likely to follow ICF. You should also confirm your answers to the ICF questions one to nine in the text box for each ICF project partner.

Contact us if you are unsure if your application should follow ICF. Find contacts in the ‘Contact details’ section

In addition to the project partner information completed in the previous section, 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 industry or company project partner.

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 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 fully flexible contribution or gated contribution (based on the IP sharing arrangements with the industry or company partner).
  5. Outline the pre-existing IP (‘background IP’) that each partner, including the academic partner, will bring to the collaborative research project and the terms under which 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:
    • who will own this IP
    • what rights industry or company 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 industry or company partners
  7. Outline any restrictions to dissemination of the project results, including the rights of the industry or company 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 industry or company project partners and describe how they will be managed.
  9. Justify collaborating with an overseas industry or company under ICF (if applicable).

Failure to provide the information requested for industry or company 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 with your technology transfer or contracts office before applying.

For audit purposes, UKRI requires formal collaboration agreements to be put in place if an award is made. You must provide us with a copy of the collaboration agreement, signed by all partners, before an ICF award starts.

If this does not apply to your proposed work, 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)

What are the ethical and RRI considerations, 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 and RRI considerations, including both the research or topic area itself and the design and delivery of the project
  • the wider implications of the proposed work, and how you will maximise the positive societal, environmental, and economic benefits arising from the project, whilst minimising unintended negative impacts, such as research misuse or accidental harm
  • how you will manage these considerations throughout the lifecycle of the project

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.

Please refer to the UKRI position statement on funding ethical research and Responsible innovation for more information around our expectations on ethical and responsible research and innovation.

Animal Involvement and”3Rs”

You must complete this section about how your proposed project will involve or impact animals.

If your project does not involve or impact animals, you must confirm this on the next page.

You may be asked about:

  • what animals you are involving
  • the severity of the procedures you are using
  • where the procedures will take place
  • welfare standards you aim to meet
  • the relevance of your project to the development, validation or dissemination of the 3Rs

You may also need to download, complete, and upload at least one set of additional questions. You will be told how to do this towards the end of this section.

To complete this section and check whether your project is in the scope of the questions, refer to the UKRI policy for research and innovation involving animals.

What counts as an animal

UKRI policy relates to all animals in the Kingdom Animalia, including vertebrates and invertebrates.

Genetically modified organisms and biological risk

You must complete this section if your project will include genetically modified organisms or genetic technologies.

If your project does not involve genetically modified organisms or genetic technologies, you must confirm this on the next page.

You may be asked about:

  • the type of organism your project will involve and the procedures your project will include
  • the intended use of the organism or genetic technology
  • the genetic, biological and environmental risks of your project

For more information, see UKRI’s guidance on genetic technologies.

Human participation in Health-related Research

You must complete this section about whether your project will include human participation.

If your project does not involve human participation, you must confirm this on the next page.

You may be asked about:

  • what type of human participation your project includes
  • the project design for human participation
  • the phase of the clinical trial
  • whether the project will be in an NHS setting, if so how the project will be registered
  • whether diversity and inclusion will be considered

For more information, see UKRI’s guidance for human participants in research.

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 £25,000
  • 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’
  • costs for public and patient involvement and engagement. Costs for public partnerships including payments to public partners
  • costs for preserving, long-term storage, or sharing of data
  • cost 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 they are associated with NHS studies
  • animal costs, such as numbers that need to be bred or maintained and to maintain high welfare standards
Outsourcing work

We recognise that sometimes it may be appropriate to outsource elements of your work to a subcontractor. If that is the case, provide the following:

  • 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 costs of the outsourced activity and the tendering process to be followed
  • details of any conflicts of interest (potential or actual) between parties and how they will be managed

You can request costs associated with reasonable adjustments where they increase as a direct result of working on the project. For further information see Disability and accessibility support for UKRI applicants and grant holders. Where a funding limit is imposed on the opportunity, requested costs for reasonable adjustments may exceed the maximum funding amount.

Assessors are not looking for detailed costs or a line-by-line breakdown of all project resources. 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

Trusted Research and Innovation (TR&I)

Trusted Research and Innovation is the protection of the UK’s intellectual property, sensitive research, people, and infrastructure from potential theft, misuse, and exploitation.

Organisations receiving UKRI funding are obliged to act in line with UK government legislation. They are also expected to undertake appropriate due diligence assessments of organisations involved in research partnerships, collaboration agreements, and commercial contracts.

You will be asked about:

  • which areas of the National Security and Investment (NSI) Act your project relates to
  • who you intend to collaborate with and how
  • if your project requires an export control licence

Your answers may affect the T&Cs of your funding agreement if you are successful. We may use your answers to determine that our current T&Cs are sufficient or if additional T&Cs are required.

How we will assess your application

Assessment process

We will assess your application using the following process.

Expert review

We will invite experts to review your application independently, against the specified criteria for this funding opportunity.

You will not be able to nominate reviewers for applications on the new UK Research and Innovation (UKRI) Funding Service. Research councils will continue to select expert reviewers.

We are monitoring the requirement for applicant-nominated reviewers as we review policies and processes as part of the continued development of the new Funding Service.

Panel

Following expert review, we will invite experts to collectively review your application and rank it alongside other applications, after which the panel will make a funding recommendation.

MRC will make the final funding decision.

Find out more about MRC’s assessment process and funding meetings.
The decisions of the MRC Proof of Concept panel are not open to appeal.

For more information on how we prioritise applications for funding please visit How we make decisions.

Feedback

We will notify you of the outcome of your application within 10 working days of the panel meeting. We will share panel and expert reviewer feedback within eight weeks of the panel meeting.

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 UKRI principles of assessment and decision making.

Using generative artificial intelligence (AI) in expert review

Reviewers and panellists are not permitted to use generative AI tools to develop their assessment, including to correct language, spelling, grammar and formatting. Using these tools can potentially compromise the confidentiality of the ideas that applicants have entrusted to UKRI to safeguard.

For more detail see our policy on the use of generative AI.

Assessment areas

The assessment areas we will use are:

  • opportunity and market
  • scientific background and current stage of development
  • development plan and route to patient benefit
  • capability of the applicants and team to deliver the project
  • intellectual property and its management
  • ethical and responsible research and innovation considerations of the project
  • resources requested to do the project

We will also assess your approach to the project, including:

  • project plan and milestones
  • methodology and experimental design
  • reproducibility and statistical design
  • risk management
  • research environment and infrastructure
  • plans for patient and public involvement
  • data management and sharing plans

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

Contact details

Get help with your application

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

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, content or remit of a funding 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 application 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 the relevant DPFS programme manager or email dpfsanddcs@mrc.ukri.org

For general questions related to MRC funding including our funding opportunities and policy email 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 more efficiently, 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.

Additional info

Support for applicants

You are strongly encouraged to engage with your organisation’s research office or translational research office who will be able to offer guidance and support.

Ethics and regulatory approval

We do not require ethics permissions and regulatory approvals to be in place when you submit an application (stage one or stage two). However, given that research involving human subjects or requiring the use of human tissue or organs may raise various ethical and regulatory issues, you will be required to demonstrate that you have adequately considered these matters.

Early discussions with regulatory bodies are advised to ensure that all requirements can be met in a timely manner. Once an application is successful, it is the responsibility of the host organisation to ensure that the appropriate ethics and regulatory approval has been obtained and that no research requiring such approval is initiated before it has been granted.

Resources

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

The MRC Centre for Research Policy and UKRI Good research resource hub webpages provide advice and resources around ethics and integrity, responsible research and innovation and public partnerships.

The National Institute for Health and Care Research provides a clinical trials toolkit that gives practical advice to those planning or running clinical trials in the UK.

Applicants developing technologies involving artificial intelligence should consider the MRC’s interim guidance for biomedical AI and software developers.

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

The MHRA Innovation Office provides free advice to clarify regulatory requirements from an early stage of product development.

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

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.

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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