Funding opportunity

Funding opportunity: Experimental medicine stage one

Apply for funding to investigate the causes, progression and treatment of human disease.

Your project must:

  • include an experimental intervention or challenge in humans
  • focus on a mechanistic hypothesis
  • be academically-led

You must be based at an eligible research organisation.

There is no limit to the amount of funding you can apply for or the length of your project. We will fund 80% of your project’s full economic cost.

This is an ongoing funding opportunity with an annual budget of £10 million. Stage one application rounds close every April and October.

Who can apply

Before applying for funding, check the following:

UK Research and Innovation (UKRI) is introducing new role types for opportunities being run on the new Funding Service. For full details, see eligibility as an individual.

Who is eligible to apply

To be eligible to apply for this 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
  • focus your application on a mechanistic hypothesis that investigates the causes, progression and treatment of human disease and uses an experimental intervention or challenge in humans

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 the project and the applicants will be provided, including mentorship and career development for early career researchers

International co-leads

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

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

Read MRC’s guidance on flexible working and career breaks. You can also find out more about MRC’s current EDI initiatives and equality, diversity and inclusion at UKRI.

What we're looking for

Scope

You can apply for academically led experimental medicine projects that are conducted in humans. Your project should be based round a clearly articulated gap in understanding of human pathophysiology and have a clear path to clinical impact.

Successful projects will produce new mechanistic insights, including those that may:

  • identify opportunities to modify disease pathways
  • enable the future development of novel therapeutic or diagnostic approaches

We welcome applications in all disease areas and interventions.

What your application must include

Your application must involve an experimental intervention or challenge in humans, which has been designed to validate a mechanistic hypothesis. The challenge may be, but is not limited to:

  • pharmacological
  • immunological
  • physiological
  • psychological
  • Infectious

Activities we support

The following types of work are eligible for support:

  • the use of novel readouts or technologies related to early evaluation of clinical efficacy or pathogenic mechanism
  • the use of drugs, other interventions or measures with established safety profiles in new settings or conditions (for example, repurposing drugs as tool compounds to probe disease mechanism)
  • characterisation or phenotyping of subjects using samples from clinical studies may be included where there is a clear link to a current treatment strategy but should not be the sole focus of the proposal:
    • limited, hypothesis-driven, retrospective sample analysis may be included at the start of the project to improve the design of the interventional, experimental medicine study
    • milestone criteria should clearly detail what data is required from the confirmatory analysis for the project to progress

Prospective, nested studies within a larger cohort trial may be eligible provided they:

  • can demonstrate added value
  • are exploring disease mechanisms
  • test a novel hypothesis
  • address a different question to the main study

Competitive applications will aim to address a clear mechanistic question and provide strong rationale to justify the suitability of the experimental system proposed to test the presented hypothesis.

Activities we do not support

The following activities are ineligible for support:

We encourage you to contact us first at support@funding-service.ukri.org to discuss your application, especially if you believe your research may cross MRC or research council interests. If your application fits another research board remit better, we may decide to transfer it there to be assessed.

Duration

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

Milestones

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

Experimental medicine awards will typically have two milestones with specific success criteria that reflect major progress points and allow mechanistic hypotheses to be laid out and evaluated as the project progresses.

Your milestones should also provide a realistic indication of timelines for key steps, such as 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 / 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 funding you can apply for. Applicants typically apply for £1 million or more. 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 Development Assistance Countries (DAC) list countries.

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

What we will not fund

We will not fund:

  • research involving randomised trials of clinical treatments
  • costs for PhD studentships
  • publication costs
  • funding to use as a ‘bridge’ between grants

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 a company letter of support 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 ‘project 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

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 (PDF, 50KB) set out UKRI’s expectations of organisations funded by UKRI in relation to due diligence for international collaboration.

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

Further guidance and information about TR&I – including additional where applicants can find additional support.

Find out about getting funding for international collaboration.

How to apply

UK Research and Innovation (UKRI) Funding Service

We are running this funding opportunity on the new 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 UKRI 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.

To apply:

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

  1. Confirm you are the project lead.
  2. Sign in or create a Funding Service account. To create an account, select your organisation, verify your email address, and set a password. If your organisation is not listed, email support@funding-service.ukri.org
  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 UKRI Funding Service. All questions and assessment criteria are listed in the How to apply section on this Funding finder page.
  4. Send the completed application to your research office for checking. They will return it to you if it needs editing.
  5. Your research office will submit the completed and checked application to UKRI.

Watch our research office webinars about the new UKRI Funding Service.

Deadline

We must receive your application by 4 October 2023 at 4:00pm UK time.

You will not be able to apply after this time. We will not consider late applications.

You should ensure you are aware of and follow any internal institutional deadlines that may be in place.

Following the close of 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.

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.

Outcomes publication

We will publish the outcomes of this funding opportunity at board and panel outcomes – MRC.

If your application is successful, some personal information will be published via the UKRI Gateway to Research.

UKRI Funding Service: section guidance

Summary

In plain English, provide a summary that can be sent to potential reviewers to determine if your proposal is within their field of expertise.

This summary may be made publicly available on external facing websites, so please ensure it can be understood by a variety of readers, for example:

  • opinion-formers
  • policymakers
  • the general public
  • the wider research community.
Guidance for writing a summary

Succinctly describe your proposed work in terms of:

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

Word count: 550

Core team

List the key members of your team and assign them roles, for example:

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

Only list one individual as project lead.

Find out more about UKRI’s new grant roles.

Section: Related Applications

Question: Is this application a re-submission of a previous experimental medicine stage one or stage two application and, if so, how have you considered and acted on the feedback you received?

What the assessors are looking for in your response:
  • please enter N/A into the text box if this is your first time applying to experimental medicine stage one for your proposed research
  • if your application is a resubmission, describe how feedback on your previous the stage one or stage two application has been considered and acted on
  • if your application is a resubmission, provide succinct responses to the panel’s comments on your previous stage one application

Word count: 1,500

Section: Vision

Question: What are you hoping to achieve with your proposed work?

What the assessors are looking for in your response

Explain how your proposed work:

  • is of excellent quality and importance within or beyond the field(s) or area(s)
  • has the potential to advance current understanding, generates new knowledge, thinking or discovery within or beyond the field or area
  • is timely given current trends, context and needs
  • impacts world-leading research, society, the economy or the environment

Within the Vision section we also expect you to:

  • outline the current clinical challenge, healthcare burden or knowledge gap
  • summarise the current state of understanding about the relevant mechanisms of disease
  • identify the current gap in mechanistic understanding
  • state the mechanistic hypothesis to be tested
  • include any relevant figures
  • provide only a small selection of images that complement the written content in a section
  • include within the image itself only text that is an integral part of it
  • include a brief description of the image within the “Alternative description” text field, so that screen reader software can describe the image to meet accessibility requirements
  • include all other text associated with the description of the image, such as the figure number, figure title and figure legend, within the narrative text so that it can be read by screen readers and contribute to the word count of a section.

Word count: 500

Section: Intervention

Question: What is the planned intervention?

What the assessors are looking for in your response

Explain the planned intervention to be used in the proposed work, including:

  • the type of intervention, which may include compound, biologic, psychological, physiological, or infection
  • relevant background information, including its established safety profile and use in other mechanistic studies
  • include any relevant figures

Provide only a small selection of images that complement the written content in a section, include:

  • within the image itself only text that is an integral part of it
  • a brief description of the image within the “Alternative description” text field, so that screen reader software can describe the image to meet accessibility requirements
  • all other text associated with the description of the image, such as the figure number, figure title and figure legend, within the narrative text so that it can be read by screen readers and contribute to the word count of a section

Word count: 250

Section: Approach

Question: How are you going to deliver your proposed work?

What the assessors are looking for in your response

Within the Approach section we expect you to:

  • provide an outline project plan, including project milestones and timelines, demonstrating:
    • how you propose to address the identified gap in knowledge
    • the objectives of the proposed research in order of priority
    • the primary and secondary experimental outcomes and how they relate to the experimental objectives
    • how the proposed work packages will ensure the project objectives are achieved
    • the success criteria that will be used for each Milestone, detailing the robust Go / No-Go criteria

To visualise your project plan, you must also upload a one-page Gantt chart to support your response that should include:

  • project tasks (these being short, achievable and measurable activities) with, where relevant, the party responsible for delivering the task and dependency relationships between tasks
  • at least two progression milestones (to include the project end goal), these being major specifically-timed decision points

Within the Approach section we also expect you to:

  • outline the proposed methodology and experimental design, including:
    • the experiments you will undertake to probe the stated hypothesis
    • the data you will collect and how it will test the hypothesis
    • the proposed trial design and why this approach is appropriate to meet the study objectives
    • the statistical analysis plan, providing sufficient details for the replication of any sample size calculations; and consideration of potential sources of biases and the strategies that will be adopted to minimise their effects
  • As part of your methodology and experimental design, outline the nature of human participation in your proposed work, including:
    • the characteristics of the participants (such as age, disease) and the rationale for their selection
    • the specific population groups in relation to their diversity characteristics and the proposed analysis, following the MRC embedding diversity in research design policy
    • target and acceptable levels of participant recruitment across the project timeline
    • evidence of recruitment feasibility
    • the human participant recruitment strategy, including the steps that will be taken if patient recruitment does not reach the set targets
    • if applicable, outline how any limited animal, library specimen or isolate cell work will inform the human-centric proposed work. For any research involving animals and tissues and cells, you must show how you will use both sexes. If you are not proposing to do this, a strong justification is required
  • outline the project risks and risk management, including:
    • how likely the risks are to occur
    • what their impact would be on the success and deliverability of the project
    • your risk mitigation strategy, giving particular consideration to any potential safety risks and how these risks will be controlled
  • demonstrate access to the appropriate services, clinical support, facilities, infrastructure, or equipment to deliver the proposed work, including details of:
    • specialist equipment or infrastructure required to deliver the project objectives
    • the use of existing clinical infrastructure such as Experimental Cancer Medicine Centres, NIHR Biomedical Research Centres, NIHR Clinical research facilities, patient cohorts

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

  • project plan and milestones 500 words
  • methodology and experimental design 500 words
  • risk management 300 words
  • infrastructure and equipment 200 words

include any relevant figures:

  • provide only a small selection of images that complement the written content in a section
  • include within the image itself only text that is an integral part of it
  • include a brief description of the image within the “Alternative description” text field, so that screen reader software can describe the image to meet accessibility requirements
  • include all other text associated with the description of the image, such as the figure number, figure title and figure legend, within the narrative text so that it can be read by screen readers and contribute to the word count of a section.

Word count: 1,500

Section: Applicant and team capability to deliver

Question: 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

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.

Word count 1,500

Section: References

Question: List the references you’ve 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.

Word count: 250

Section: Project Partners

Question: Provide details of any project partners’ contributions, and letters or emails of support from each named partner.

What the assessors are looking for in your response

Download and complete the Project partner contributions template (DOCX, 52KB).

Each letter or email you provide should:

  • 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

Save letters or emails of support from each partner in a single PDF no bigger than 8MB. Unless specially requested, please do not include any personal data within the attachment.

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’.

If the attachment does not meet these requirements, the application will be rejected.

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

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

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

Do not provide letters of support from host and project co-leads’ research organisations.

Word count: 1,000

Section: Outline costs

Provide costs that reflect, as accurately as possible, the funding you will need.

Section: Ethics and Responsible Research and Innovation (RRI)

Question: 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

Using the text box, demonstrate that you have identified and evaluated the relevant ethical or responsible research and innovation considerations, and how you will manage them.

Consider the MRC guidance on ethics and approvals

If you are collecting or using data you should identify:

  • any legal and ethical considerations of collecting, releasing or storing the data including consent, confidentiality, anonymisation, security and other ethical considerations and, in particular, strategies taken to not preclude further re-use of data
  • formal information standards with which study will be compliant

Word count 500

How we will assess your application

Assessment process

We will assess your application using the following process.

Your application will be assessed in a two-stage process. Your stage one application will first be considered by an independent panel of experts.

If successful, you will be invited to submit a stage two application. This undergoes external peer review before a further and more detailed review by the panel.

Timescale

We aim to complete the process from stage one submission to stage two decision in approximately 30 weeks.

Feedback

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 (DORA) 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 criteria

The criteria against which your stage one application will be assessed directly relates to the application questions. The panel will assess your application on the following criteria:

  • fit to the funding opportunity scope
  • vision of the project
  • approach to the project – including:
    • project plan & milestones
    • methodology, experimental and statistical design
    • risk mitigation and management
    • research environment and infrastructure
  • capability of the applicants and team to deliver the project
  • ethical and responsible research and innovation considerations of the project

Contact details

Get help with your application

For help on costings and writing your application, contact your research office. Allow enough time for your organisation’s submission process.

Ask about this funding opportunity

Email: support@funding-service.ukri.org

We aim to respond to emails within two working days.

Phone: 01793 547490

Our phone lines are open:

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

Sensitive information

If you, or a key team member, need to tell us something you wish to remain confidential, email support@funding-service.ukri.org. Include ‘Sensitive information: Experimental Medicine Stage One’ in the subject line.

Typical examples of confidential information include:

  • applicant 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, see UKRI’s privacy notice.

Additional info

Background

Support for Applicants

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

Guidance is available on the MRC Regulatory Support Centre, developed in collaboration with the Health Research Authority, for those conducting research with human participants, their tissues or data.

The vast majority of studies that involve human participants, their tissues or data should undergo a research ethics committee (REC) review and many research studies may require an NHS REC opinion. The HRA Decision Tool can be used to determine whether your study requires this type of approval.

The Integrated Research Application System (IRAS) should be used when applying for NHS REC approval and for other regulatory approvals. IRAS is a single system for applying for the permissions and approvals for health and social/community care research in the UK.

Prior to the establishment of the Experimental Medicine Panel, we ran four experimental medicine challenge grant funding opportunities. As part of these, a webinar was held to articulate the remit, what qualifies as good experimental medicine, challenges identified from previous rounds and how successful applications were designed, reviewed and conducted.

You may find the webinar recording useful in preparing an experimental medicine application.

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 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.

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

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.