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Grant Analysis

Purpose & Target

This funding opportunity, by invitation only, supports academic-led experimental medicine projects focused on human disease. The core objective is to investigate the causes, progression, and treatment of human disease by testing clearly articulated mechanistic hypotheses through experimental interventions or challenges in humans. The grant targets UK-based eligible research organisations and actively encourages 'new investigators' (early career researchers transitioning to independence). It is SECTOR-SPECIFIC, focusing on medical and health research, particularly in bioscience and clinical fields. This is an ongoing funding opportunity, requiring a successful Stage One application for an invitation to apply for Stage Two.

Financial Structure

Total Funding and Grant Size

Total Funding Opportunity: The overall fund for this opportunity is £10,000,000.
Grant Size per Project: There is no stated maximum limit to the funding you can apply for per project. However, applicants typically apply for £1,000,000 or more.

Funding Rate

Full Economic Cost (fEC): The grant will fund 80% of your project's full economic cost.
Permitted Exceptions: 100% of permitted exceptions will be funded.

Eligible Costs Funding can be requested for a range of costs, including: * Salaries: A contribution to your (project lead's) salary (for new investigators, up to 50% of total working time), and a contribution to co-leads' salaries. * Staff Costs: Support for other research and technical staff posts. * Direct Costs: Research consumables, equipment (justification needed for items >£25,000), travel costs, data preservation, data sharing, and dissemination costs. * Indirect Costs: Estates and indirect costs. * NHS Research Costs: Costs associated with NHS studies (requires a completed and authorized 'Schedule of Events Cost Attribution Tool (SoECAT)' export). * Public Partnerships: Costs related to public partnerships and activities, including payments to public contributors (can be included under exceptions). * International Co-Leads: Costs for work undertaken at international organisations by international project co-leads are funded at 100% of eligible costs. * For international applicants from high-income countries (not on the OECD DAC list), India, and China, these costs must not exceed 30% of the total resources requested. * For international applicants from development assistance countries (DAC), there is no cap on costs requested. * Reasonable Adjustments: Costs associated with reasonable adjustments due to disability. Ineligible Costs Costs that will not be funded include: * Efficacy-focused treatment trials. * PhD studentships. * Publication costs. * Funding to be used as a 'bridge' between grants. Co-financing and Matching Funds

Given the 80% funding rate for full economic costs, applicants are expected to cover the remaining 20% from their own resources or other sources.

Project Partner Contributions

Project partners can support your research through cash or in-kind contributions. In-kind contributions may include staff time, access to equipment, sites or facilities, provision of data, software or materials, and recruitment of participants.
Minor costs for project partners, such as travel and subsistence, can be claimed and justified within the application's resources and costs section.

Financial Reporting

While specific financial reporting mechanisms are not detailed in this document, it is implied that successful applicants will be subject to UKRI's standard financial reporting and audit requirements, especially regarding justified costs and milestones.
For NHS research costs, the 'Schedule of Events Cost Attribution Tool (SoECAT)' is required for cost attribution and to ensure full site-level research costs are recovered.

Budget Flexibility

You should justify the resources needed in the context of the proposed work. Assessors look for comprehensive, appropriate, and justified resource requests that represent optimal use and maximise outcomes.

Eligibility Requirements

Organizational Eligibility

Invitation-Only: You can only apply if you have been invited following a successful Stage One application.
Eligible Research Organisation: Your lead organisation must be a UK-based 'eligible research organisation'. You should check if your specific organisation is eligible with UKRI.
NHS Organisations: If the lead research organisation is an NHS organisation, ensure it is set up in the UKRI Funding Service; additional steps may be required.

Individual Eligibility (Project Lead)

Active Engagement: You must show that you will direct the project and be actively engaged in the work.
Stage One Involvement: You must have been part of the team that submitted a successful Experimental Medicine Stage One application.
Contract Duration: If your employment contract does not cover the full duration of the proposed project, your research organisation must confirm that contracts will be extended and all necessary support (including mentorship for early career researchers) will be provided if successful.

International Researchers

Project Co-Lead (International): International researchers can apply as 'project co-lead (international)'. Their contribution and added value must be clearly explained and justified.
Project Partners: All other international collaborators should be included as 'project partners'.

New Investigator Applicants (Early Career Researchers)

Goal: This stream is for researchers ready to take the next step towards becoming independent researchers.
Required Support: Must have support from their research organisation.
Skills and Experience: Must demonstrate skills and experience matching the 'transition to independence' career stage as defined by the MRC skills and experience table.
Career Alignment: The grant must support your long-term career goals and chosen career route.
Intellectual Leadership: You must be the sole intellectual leader of the application and proposed work, with team members bringing essential complementary expertise (not replacing your leadership).
Eligible Roles: You can apply if you are:
- A postdoctoral research assistant (grant starts after current work finishes).
- Hold a lecturer appointment, a junior fellowship, or another research staff position.
- Hold, or have held, an early career training fellowship (e.g., MRC skills development fellowship).
- Do not have a contract with your chosen host organisation, or are not currently based there, but the organisation has agreed to host your award.
- Are a non-clinical or clinically active researcher.
- Have any number of years of experience.

Ineligible as a New Investigator

Already Independent: You are ineligible if you have already achieved independence. This typically means you have previously led a research team or been awarded a substantial grant (3+ years, salary support for 1+ team member).
Prior Transition Award: You have held an award that facilitates the transition to independence.
Repeated Application: You have applied for a new investigator grant twice before.
Pending UKRI Fellowships: You have an application for any UKRI fellowship (e.g., Career Development Award, Clinician Scientist Fellowship, Future Leaders Fellowships) currently under consideration.

Scope Limitations & Exclusions

Experimental Intervention in Humans: Projects must involve an experimental intervention or challenge in humans, with established safety profiles, designed to validate a mechanistic hypothesis.
Activities NOT Supported: The grant will not fund:
- Characterisation or phenotyping work aiming to elucidate disease aetiology (covered by MRC research boards).
- Biomarker discovery (covered by MRC research boards).
- Experimental intervention or challenge in animals using clinical assets (covered by MRC research boards).
- Development and evaluation of novel therapeutics, diagnostics, or devices (covered by MRC Developmental Pathway Funding Scheme).
- High-throughput screening approaches to target validation.
- Pre-clinical model development and validation (covered by MRC research boards).
- Clinical efficacy trials (covered by NIHR MRC Efficacy and Mechanism Evaluation funding scheme).
- Observational studies involving no experimental challenge.
- PhD studentships.
- Publication costs.
- Funding to be used as a 'bridge' between grants.

Partnership/Consortium Requirements

Team Science: The grant supports team science and interdisciplinary research. You can include project co-leads (UK and international), specialists, and other team roles.
Project Partners: You can include project partners (e.g., industry, academia, third sector, government organisations in the UK or overseas) who will contribute cash or in-kind support (staff time, equipment access, data, software, materials, participant recruitment).
- Project partners cannot be core team members or from the same organisation as core team members.
- Each project partner must provide a statement of support.
- Industry partners will likely need to comply with the 'Industry Collaboration Framework (ICF)'.

Application Process

Application Platform and Process

Platform: Applications must be submitted through the new UK Research and Innovation (UKRI) Funding Service. You cannot use the Joint Electronic Submissions (Je-S) system.
Invitation Required: This is an invited stage two application. You must have received an invitation after a successful Stage One application to be eligible to apply.
Project Lead Responsibility: The project lead is responsible for completing the application on the Funding Service.
Organisation Registration: Ensure your organisation is registered on the Funding Service. If not, email support@funding-service.ukri.org (allow at least 10 working days for setup).
Submission Steps:
1. Confirm you are the project lead.
2. Sign in or create a Funding Service account.
3. Answer questions directly in text boxes or prepare offline and paste.
4. Upload required documents as specified.
5. Allow time to check your application in 'read-only' view.
6. Send the completed application to your research office for checking.
7. Your research office will submit the application to UKRI.

Key Dates and Deadlines

Publication Date: 30 June 2025
Opening Date: 8 July 2025, 9:00am UK time
Closing Date: 3 September 2025, 4:00pm UK time
Internal Deadlines: Be aware of and follow any internal institutional deadlines, as your research office must submit the application.
No Changes After Submission: Once submitted, applications cannot be changed or returned for amendment. Non-compliance with guidance may lead to rejection.

Required Documentation and Materials All word limits are strict. Visual elements (images, Gantt charts) must include captions and convey important visual information. * Summary (550 words): Plain English summary for public release, suitable for expert assessment. * Core Team: List key members and assign roles (e.g., Project Lead, Project Co-Lead, Specialist). * Related Applications (2,000 words): Detail how feedback from the Stage One application was considered and acted upon. * New Investigators (Yes/No) (1 word): * New Investigator Grant: Eligibility (250 words): Justify your eligibility as a new investigator. * Vision (1,100 words): Explain what you hope to achieve, its quality, importance, potential to advance knowledge, timeliness, and impact. * Intervention (550 words): Describe the planned experimental intervention, its type, safety profile, development history, and IP. * Approach (3,500 words): Detailed project plan (including timelines/Gantt chart), objectives, methodology, experimental design, human participation, risk management, research environment, and dissemination plans. * Reproducibility and Statistical Design (500 words): How reliability, robustness, and reproducibility will be ensured, including statistical analyses. * Project Milestones (1,500 words): Provide at least two key progression milestones using the provided 'Experimental Medicine milestone template' (DOCX, 62KB), which must be pasted into the text box. Milestones must be SMART (Specific, Measurable, Achievable, Relevant, Time-framed) with 'Go' or 'No-Go' criteria. * Data Management and Sharing (1,500 words): Provide a data management plan following MRC's template and policies. * New Investigator Grant: Career Development (250 words): Explain how the award will support your career goals and development of independence. * Applicant and Team Capability to Deliver (2,200 words): Use the 'Résumé for Research and Innovation (R4RI)' format to demonstrate experience, skills, and leadership. * New Investigator Grant: Research Organisation Support (1,000 words): Statement from your research organisation head of department or senior manager committing support. * Project Partners: Add details of any collaborating organisations. * Project Partners: Letters (or Emails) of Support (10 words): Upload a single PDF containing letters/emails of support from each named project partner. These should explain their commitment, value, and benefits to them (max two sides A4 per partner). * Industry Collaboration Framework (ICF) (1,500 words): If collaborating with industry/company project partners, confirm ICF applies and answer specific questions related to the collaboration. * Trusted Research and Innovation (TR&I) (100 words): Demonstrate how your work relates to UKRI's TR&I principles (dual-use, NSI Act, export control). * International Collaboration (100 words): List countries of international co-leads, partners, or collaborators. * Ethics and Responsible Research and Innovation (RRI) (500 words): Describe ethical/RRI implications and how they will be managed. * Genetic and Biological Risk (700 words): If applicable, identify risks, implications, and mitigation plans. * Research Involving the Use of Animals (10 words): If applicable, complete and upload a specific template (DOCX converted to PDF) detailing animal research. * Conducting Research with Animals Overseas (700 words): If applicable, provide a statement confirming adherence to UK welfare standards for overseas animal research, potentially with specific checklists. * Resources and Cost Justification (1,000 words): Justify the costs of key resources needed for the project. * Clinical Research Using NHS Resources (250 words): If conducting clinical research in the UK using NHS resources, you must complete and upload the 'study information' and 'summary' pages from the 'Funder Export' of a completed and authorised 'Schedule of Events Cost Attribution Tool (SoECAT)'. Application Assistance

Specific Opportunity Questions: Contact [email protected].
General MRC Funding Questions: Contact [email protected].
Funding Service System Issues: Contact support@funding-service.ukri.org or call 01793 547490 (Mon-Thu 8:30am-5:00pm, Fri 8:30am-4:30pm UK time).
Costing and Proposal Writing: Contact your research office in the first instance.

Evaluation Criteria

The assessment of your application will focus on the following key areas: Vision of the Project

Quality and Importance: Is the proposed work of excellent quality and importance within or beyond its field?
Knowledge Advancement: Does it have the potential to advance current understanding, or generate new knowledge, thinking, or discovery?
Timeliness: Is the project timely given current trends, context, and needs?
Impact: How will it impact world-leading research, society, the economy, or the environment?
Clinical Challenge and Hypothesis: Clearly articulate the current clinical challenge, healthcare burden, or knowledge gap. Summarise existing understanding, identify gaps in mechanistic understanding, and state the mechanistic hypothesis to be tested.
Benefits: Identify potential direct or indirect benefits, target beneficiaries, and improvements in human or population health. Explain the route to patient benefit and whether results will be valuable for 'discovery science' through 'reverse translation'.

The Intervention

Clarity and Background: Explain the planned experimental intervention, including its type (e.g., pharmacological, immunological, physiological, psychological, infectious), relevant background information (established safety profile, use in other mechanistic studies), development history, and any existing intellectual property.

Capability of the Applicants and Team

Experience and Skills: Demonstrate that you (and your team) have the relevant experience and appropriate balance of skills and expertise to deliver the proposed work.
Leadership and Management: Evidence of appropriate leadership and management skills and an approach to develop others.
Research Environment Contribution: How you have contributed to developing a positive research environment and wider community.
R4RI Format: Use the 'Résumé for Research and Innovation (R4RI)' format to showcase skills and past contributions, emphasizing key skills each team member brings.

Ethical and Responsible Research and Innovation (RRI) Considerations

Identification and Management: Demonstrate that you have identified and evaluated all relevant ethical or RRI considerations and how you will manage them. This includes addressing potential genetic or biological risks and animal research ethics.

Career Development and Research Organisation Support (for New Investigator Applications ONLY)

Career Goals: Explain how this award will contribute to your long-term career goals, help develop your research profile, foster independence, aid in securing future grants, and establish/lead a research team.
Wider Community Impact: Demonstrate how you will instigate positive change in the research and innovation community (e.g., through equality, diversity, and inclusion advocacy, peer review, policy influence, public engagement).
Organisational Commitment: Provide a clear statement of commitment and support from your research organisation, detailing how your expertise fits, training/development opportunities, mentoring arrangements, financial support, post-award support, and integration into the research environment.

Resources Requested

Justification: Justify the application's more costly resources, such as project staff, significant travel, equipment over £25,000, exceptional consumables, facilities, and 'Exceptions' (like NHS research costs or public contributor payments).
Appropriateness: Demonstrate that requested resources are comprehensive, appropriate, and justified, representing optimal use to achieve intended outcomes and maximise potential impact.

Approach to Project Work

Project Plan and Milestones: Provide a detailed project plan with timelines (e.g., Gantt chart), clear objectives, primary and secondary experimental outcomes. Include at least two key progression milestones that are SMART (Specific, Measurable, Achievable, Relevant, Timely) with robust 'Go' or 'No-Go' criteria and quantified target/acceptable values.
Methodology and Experimental Design: Detail experiments to probe the hypothesis, data collection methods, trial design, and justification. Describe human participation (characteristics, recruitment feasibility, strategy, approvals). Discuss risk management, including likelihood, impact, and mitigation strategies.
Reproducibility and Statistical Design: Explain how reliability, robustness, and reproducibility will be ensured, including statistical analyses, sample and effect sizes, chosen models, potential sources of bias, and how diversity is addressed in experimental design.
Research Environment and Infrastructure: Describe how your research environment contributes to success and demonstrate access to necessary services, facilities, infrastructure, or equipment.
Patient and Public Involvement (PPI) and Dissemination: Outline plans for engagement, communication, and dissemination with the research community, wider audiences, and public/patients.
Data Management and Sharing: Provide a data management plan detailing compliance with MRC's policies and template.

Cross-Cutting Themes

Equality, Diversity, and Inclusion (EDI): Considered across the application, with encouragement for diverse applicants and support for career breaks and flexible working. The impact of COVID-19 related disruption will also be considered.
Trusted Research and Innovation (TR&I): Applicants must demonstrate how their project complies with UKRI's TR&I principles, including disclosing dual-use applications, relevance to the UK National Security and Investment (NSI) Act's 17 areas, and export control requirements.
Industry Collaboration Framework (ICF): For applications with industry partners, detailed information is required on collaboration nature, IP management, and potential restrictions.

Compliance & Special Requirements

Regulatory Compliance

Ethics and Approvals: While ethics permissions and regulatory approvals are not required at the time of application submission, you must demonstrate that you have adequately considered these matters. If successful, the host organisation is responsible for ensuring all appropriate ethics and regulatory approvals are obtained before research begins. Early discussions with regulatory bodies are advised.
NHS Research Costs (SoECAT): For clinical research conducted in the UK using NHS resources, you must complete and submit a 'Schedule of Events Cost Attribution Tool (SoECAT)' through NIHR's Central Portfolio Management System (CPMS). The SoECAT must be authorised by an AcoRD Specialist (Attributing the costs of health and social care Research and Development). Failure to attach the required SoECAT export can lead to rejection.
Animal Research Compliance: If your proposed research involves vertebrate animals or other organisms covered by the Animals (Scientific Procedures) Act, you must comply with 'Responsibility in the Use of Animals in Bioscience Research' guidance. This includes detailing the maximum severity of procedures, Home Office approvals, justification of species used, experimental design, and statistical framework. For specific species (non-human primates, dogs, cats, equidae, pigs), additional detailed information on sourcing, husbandry, procedures, staff experience, and advances towards the 3Rs (Replacement, Reduction, Refinement) is required.
Overseas Animal Research: Any animal research conducted overseas must adhere to welfare standards consistent with those in the UK, as outlined in the 'Responsibility in the Use of Animals in Bioscience Research' document. A statement confirming this compliance is required.
Genetic and Biological Risk: If your research involves genetic or biological risks, you must identify them, their implications, and your mitigation plans. This includes genetic modification or release of GMOs.

Data Protection and Privacy

UK Data Protection Legislation: MRC, as part of UKRI, will handle personal data in line with UK data protection legislation.
Confidential Information: For sensitive information (e.g., individual unavailability, conflicts of interest, eligibility clarification), email [email protected] with specific subject line formatting.

Intellectual Property (IP) Policies

Industry Collaboration Framework (ICF): If your application includes industry or company project partners, you must comply with the MRC ICF. This requires outlining pre-existing IP ('background IP'), expected foreground IP, ownership arrangements, rights of industry/company partners to use academically-generated foreground IP, and academic partner rights to commercialise IP. Formal collaboration agreements are required if an award is made.

Trusted Research and Innovation (TR&I)

Compliance: Applicants are asked to demonstrate how their proposed projects comply with UKRI's TR&I principles.
Transparency: You must list any dual-use (military and non-military) applications, indicate if the project is relevant to any of the 17 areas of the UK National Security and Investment (NSI) Act, and confirm if an export control license is required.

Cross-Cutting Considerations

Equality, Diversity, and Inclusion (EDI): UKRI is committed to achieving equality of opportunity and encourages applications from diverse researchers. Support for career breaks, caring responsibilities, and flexible working is provided. Assessors will consider the unequal impacts of events like COVID-19 related disruptions on applicant capability.
Risk Management: Applications must include a comprehensive section on identifying and managing risks to project delivery, including likelihood, impact, and mitigation strategies. Key project milestones are intended to serve as risk mitigation and decision points.
Sustainability: The 'Vision' section requires applicants to detail the project's potential impact on society, the economy, or the environment, implying a consideration of sustainability.
Knowledge Sharing: Strong emphasis on data management and sharing plans (complying with MRC policies) and comprehensive engagement, communication, and dissemination strategies with the research community and wider public/audiences.

Grant Details