Funding opportunity

Funding opportunity: Experimental medicine stage one

Start application

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. Application rounds close every April and October. The start application link will appear when the opportunity opens 18 January 2024 9:00am.

Who can apply

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

UK Research and Innovation (UKRI) has introduced new role types for funding opportunities being run on the new UKRI Funding Service. For full details, visit Eligibility as an individual.

Who is eligible to apply

To be eligible to apply for this opportunity you must:

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 applicants

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

Find out more about 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 your application:
    • 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 experimental.medicine@mrc.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 at least 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 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 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 of 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

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

As such, 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

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 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 UK Research and Innovation (UKRI).

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

To apply

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

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

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

  • use images sparingly and only to convey important information that cannot easily be put into words
  • insert each new image onto a new line
  • provide a descriptive legend for each image immediately underneath it (this counts towards your word limit)
  • 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 17 April 2024 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

We 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: 1,500

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

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

Vision

Word limit: 1,500

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, or generate 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

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

Intervention

Word limit: 250

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

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

Approach

Word limit: 1,500

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 or No-Go criteria

To visualise your project plan, you must also provide an embedded legible 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 target
    • 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

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

Applicant and team capability to deliver

Word limit: 1,700

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 1,700 words: 1,000 words to be used for R4RI modules, 200 words to summarise the career stage of the core team (an example table will be provided within the Funding Service to assist you with your summary) 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: 250

List the references you have used to support your application.

What the assessors are looking for in your response

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

You should not include any other information in this section.

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

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

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

Project partners

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

A project partner is a collaborating third party organisation 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 during the stage two application. 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’.

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

Outline costs

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

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.

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 35 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 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:

  • 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

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 and/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 application please contact your research office in the first instance, allowing sufficient time for your organisation’s submission process.

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

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

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

Email: support@funding-service.ukri.org
Phone: 01793 547490

Our phone lines are open:

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

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

Find out more information on submitting an application.

Sensitive information

If you or a core team member need to tell us something you wish to remain confidential, please contact experimental.medicine@mrc.ukri.org

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

Typical examples of confidential information include:

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

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

Additional info

Background

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 or 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 Medical Research Council (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 some quick feedback or help us improve your experience by taking three minutes to tell us what you think of the UKRI website.