Funding opportunity

Funding opportunity: Developmental pathway funding scheme: invited stage two

Apply for funding to develop and test novel therapeutics, medical devices, diagnostics and other interventions.

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

Your project can start and finish at any stage on the developmental pathway from early development, through pre-clinical refinement and testing to early-phase clinical studies and trials (up to phase 2a).

There is no limit on the amount of funding you can apply for, but it should be appropriate to the project. We usually fund 80% of a project’s full economic cost.

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

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 develop and test novel therapeutics, medical devices, diagnostics and other interventions
  • be part of a team that submitted a Developmental Pathway Funding Scheme (DPFS) stage one application and, after successful assessment, have been invited to submit a stage two application for this opportunity. Additional team applicants can be included that were not in the stage one application

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 the ‘Applicant 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 either:

  • improve prevention, diagnosis, prognosis or treatment of significant health needs
  • develop research tools that increase the efficiency of developing interventions

All diseases and interventions are eligible for support. You can also address global health issues.

Your project can start and finish at any stage on the developmental pathway from early 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 T-cell therapy)
  • 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
  • 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)
  • clinical studies where the main aim is to investigate disease mechanism (supported by the MRC Experimental Medicine Panel)
  • late-phase clinical trials (supported by the National Institute for Health and Care Research (NIHR) efficacy and mechanism evaluation and NIHR health technology assessment programmes)
  • late-phase global health trials (supported by applied global health)

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.

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

Milestones

Milestones allow us to mitigate risk and support potentially high-risk projects.

Developmental Pathway Funding Scheme (DPFS) awards will typically have two to three milestones with specific success criteria that reflect major progress points and allow project progress to be evaluated.

Your milestones should also provide a realistic indication of timelines for key steps, such as technical development regulatory steps, study team recruitment, participant recruitment, study completion and data analysis.

Milestone success criteria should be SMART (Specific, Measurable, Achievable, Relevant, Timely), and detail any robust ‘Go or No-go’ criteria. For all projects, it is advisable to structure the project so that the critical questions are addressed as early as possible in the plan.

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

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

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.

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.

Team project partner

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

  • staff time
  • access to equipment
  • sites or facilities
  • the provision of data
  • software or materials

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

Find out more about subcontractors and dual roles.

Who cannot be included as a team project partner

The individual named as the contact for the project partner organisation cannot also be a named applicant, such as those with a role of project lead or co-lead and any other named member of staff.

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

If your application includes international applicants, project partners or collaborators, visit UKRI’s trusted research and innovation for more information on effective international collaboration.

Find out about getting funding 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.

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

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

To apply

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. 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. You should:

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

Watch our research office webinars about the new Funding Service.

For more guidance on the Funding Service, see:

Deadline

We must receive your application by 6 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

Related applications

Word limit: 2,000

Provide a response to feedback from your stage one Developmental Pathway Funding Scheme (DPFS) application or previous stage two DPFS application.

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 is being taken 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

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 a small selection of 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.

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.

Download and complete the DPFS small molecule supplementary information form DPFS small molecule supplementary information form (DOCX, 48KB), then paste the table into the text box.

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
  • use the table as a template, summarise the available data in the same column for each series. 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
  • how the proposed work will enable its development
  • 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 inform or deploy the product or technology using the most appropriate route to market or patient benefit
Exit strategy
  • 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
  • criteria that would need to be met to access the further support
  • if you are ultimately seeking to develop a commercial product, the potential market value and how this will be realised such as business development plans
  • any engagement taken place or planned with potential downstream funders, partners or regulators, outlining who they are and the status of discussions
  • the plans and strategy for further development, outlining the planned route to achieving patient benefits following the end of the DPFS project

Approach

Word count: 3,500

How are you going to deliver your proposed work?

What the assessors are looking for in your response

Provide a project plan with robust experimental design and risk management to support your development.

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)
  • project’s starting point and approaches proposed to deliver the planned objectives
  • the overall timeframe of the project
  • the resourcing necessary to deliver the proposed work
  • the project management requirements, including the commitment and involvement from your:
    • research office
    • translational research office, your technology transfer office or both (include key contact and their positions)
  • any regulatory approvals required. If you have consulted with the relevant regulatory body or experts, please summarise the outcome of the discussions

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

  • project tasks (these being short, achievable and measurable activities) with, where relevant, the party responsible for delivering the task and dependency between tasks
  • milestones which are major specifically-timed ‘Go or No-go’ decision points

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 both sexes 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
  • the statistical analysis plans, the proposed sample sizes in sufficient detail for the replication of any power calculation
  • the anticipated effects sizes and variability
  • potential sources of bias and describe the strategies that will be adopted to minimise their effects
  • for clinical studies, the recruitment and retention strategy

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.

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

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: 1,000 words
  • risk management: 500 words
  • environment, infrastructure and equipment: 500 words

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

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

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, 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

Download and complete the following milestone template (DOCX, 49KB) and copy and paste into the text box. You may add as many milestones as needed for your project.

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

  • detail robust ‘Go or No-go’ criteria (failure to meet these will result in early termination of the project)
  • for all projects, it is advisable to structure the project 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 studies. Success criteria should align to project aims and objectives; success criteria for the final milestone should reflect what success for the funded aspect of the project would equate to.

For each success criterion, please specify a quantified target value that you will seek to attain and a quantified acceptable value, which, if achieved, would support project progression.

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.

Your estimate of the milestone criteria being met should assume that the preceding milestone was achieved.

For the final milestone, the criteria should reflect outcomes representing successful completion of the project.

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 Funding 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.

Intellectual property (IP) management and dissemination of project outcomes

Word count: 1,500

Attachment: International Search Report (five pages)

What IP will be generated and how would it be managed during the project?

What the assessors are looking for in your response

If the project is not generating any new IP, please enter ‘N/A’ in the section and move on.

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 DPFS. 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
  • detail 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 DPFS 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. If access is required, what IP does the project need access to 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, and what is the nature of their interest and how are conflicts of interest being managed

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 organisation who will have an integral role in the proposed research, for example a Charity partner or, if applicable, a supplier of the project intervention. Project partners do not include project co-leads. This may include direct (cash) or indirect (in-kind) contributions such as expertise, staff time or use of facilities.

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

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

The individual, 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 partners’ 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: We are only looking for you to provide letters or emails of support from the following:

  • a third party individual
  • a third party organisation

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

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

What supporting statements we are not looking for

We are not looking for you to provide any supporting emails or letters 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 core team role cannot also be a project partner.
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
  • 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’.

Industry Collaboration Framework (ICF)

Word count: 1,500

Does your application include industry project partners?

What the assessors are looking for in your response

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

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

Important note: You must also add any industry or company collaborator to both ‘Project partners’ and ‘Project partners letters or emails of support’ sections of your application, when they are included under ICF.

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 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.

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, less complex, the plan may be as short as 500 words

Ethics and responsible research and innovation (RRI)

Word limit: 500

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

What the assessors are looking for in your response

Demonstrate that you have identified and evaluated:

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

Consider the MRC guidance on ethics and approvals.

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

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:

We recognise that in some instances it may be appropriate to outsource elements of the proposed DPFS project. If that is the case in this application, please 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 or a line-by-line breakdown of costs, they would like 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 confirm that:

  • 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 dpfsanddcs@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.

Peer 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. Expert reviewers will continue to be selected by MRC expert reviewer selectors.

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

Panel

Following peer 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.

We will make the final funding decision.

Find out more about MRC’s assessment process.

The decisions of the DPFS panel are not open to appeal.

Resubmission

You cannot re-apply with the same or a similar application to DPFS or other MRC funding opportunities if it is less than 12 months since you last applied, unless you have been invited to resubmit early.

Feedback

We will notify you of the outcome of your application within two working days of the panel meeting. We will give feedback with the outcome of your application 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 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:

  • opportunity and market
  • scientific background and current stage of development
  • development plan and route to patient benefits
  • approach to the project, including:
    • project plan and milestones
    • methodology, experimental and statistical design
    • risk management
    • data management and sharing plans
  • 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

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

Important note: The Helpdesk is committed to helping users of the 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 dpfsanddcs@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.

You can also find information on submitting an application here: Improving your funding experience.

Sensitive information

If you or a core team member need to tell us something you wish to remain confidential, email the Funding Service helpdesk on dpfsanddcs@mrc.ukri.org

Include in the subject line: [the funding opportunity title; sensitive information; your UKRI 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

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

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 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.

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

The Nucleic Acid Therapy Accelerator 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.

This is the website for UKRI: our seven research councils, Research England and Innovate UK. Let us know if you have feedback or would like to help improve our online products and services.