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Grant Analysis

Purpose & Target

Grant Purpose and Target

Core Objective: Understanding how infections foster and induce non-communicable diseases (NCDs), particularly neurodegenerative and cardiometabolic ones, to facilitate the development of improved diagnostic, preventative, and therapeutic approaches.
Target Recipient Type and Size: Legal entities, including public and private organizations, healthcare providers, research institutions, and companies engaged in healthcare-related activities.
Designation: SECTOR-SPECIFIC (Health, Medical Research, Digital Health, Life Sciences)
Geographic Scope: EU Member States and Associated Countries. Funding is not available for entities established in the UK and Canada.
Key Filtering Criteria: Focus on the interplay between infections and specific NCDs, requirement for a consortium, legal entity status, and geographic eligibility for funding.
Grant Frequency and Context: This is Topic 02 within the Innovative Health Initiative (IHI) Joint Undertaking's 11th Call, implying a recurring program with annual or regular calls.

Financial Structure

- Budget for the overall Innovative Health Initiative (IHI) JU Call 11 in 2025: 37209000.0 EUR. - Minimum grant amount for this specific topic (HORIZON-JU-IHI-2025-11-02-two-stage): 7127000.0 EUR. - Maximum grant amount for this specific topic (HORIZON-JU-IHI-2025-11-02-two-stage): 7127000.0 EUR. - Currency: EUR. - Co-financing requirement: An 'IHI additional eligibility criterion' requires a 45% industry contribution for the project. - Eligible costs: Not explicitly detailed in the provided text, but refer to 'Annex G of the Work Programme General Annexes' for legal and financial set-up of grants. Specific IHI budget items like IKOP, IKAA, FC PAID, and FC RECEIVED are mentioned as requiring specification in a compulsory annex. - Compulsory budget annexes: Applicants must submit an 'Annex to the budget and type of participants' and a 'Declaration of in-kind contribution commitment'. - Financial sustainability: A strategy to ensure the sustainability of project outputs beyond the funding period is expected.

Eligibility Requirements

Organizational Type

Eligible: Legal entities of any size, including public bodies, healthcare providers, research organizations, private entities, professional associations, companies developing wellness applications, nursing homes, day-care centers, entities providing services for people with disabilities, and orthopaedics companies.
Ineligible for funding: Natural persons and microenterprises are generally exempted from certain obligations related to health data holding, but this does not explicitly exclude them from applying for funding if they meet other criteria, however, the grant is designed for legal entities carrying out research.

Geographic Location

Eligible for funding: Legal entities established in EU Member States and countries associated with Horizon Europe. This includes: 'AT', 'BE', 'BG', 'HR', 'CY', 'CZ', 'DK', 'EE', 'FI', 'FR', 'DE', 'GR', 'HU', 'IE', 'IT', 'LV', 'LT', 'LU', 'MT', 'NL', 'PL', 'PT', 'RO', 'SK', 'SI', 'ES', 'SE', 'AL', 'BA', 'GE', 'IS', 'IL', 'MD', 'ME', 'MK', 'NO', 'RS', 'TR', 'UA'.
Ineligible for funding: Legal entities established in the UK and Canada.

Consortium Requirements

A consortium is required for application and project implementation.
Consortia must ensure an 'IHI additional eligibility criterion' of a 45% industry contribution.

Technical and Capacity Requirements

Applicants must possess the necessary expertise and capacity for Research and Innovation Actions (RIA).
Projects must leverage existing research cohorts and biobanks, with new prospective cohort launches being out of scope.
The ability to develop and/or utilize pre-clinical models is expected.
Adherence to all relevant ethical and data privacy standards for research is mandatory.

Submission Requirements (Admissibility)

Stage 1 (short proposal for RIA) has a maximum page limit of 20 pages.
Stage 2 (full proposal for RIA) has a maximum page limit of 50 pages.

Application Process

This is a two-stage submission procedure.
Applications must be submitted through the Electronic Submission Service on the Funding & Tender Opportunities Portal.

Deadlines

Stage 1 (short proposal) deadline: 2025-10-09.
Stage 2 (full proposal) deadline: 2026-04-29.

Required Documentation

For Stage 1 (Short Proposal):
- Proposal template - Part A: Generated by the IT system in the submission environment, containing general information, participant details, and overall budget.
- Proposal template - Part B - Short proposal: A separate document with a page limit of 20 pages.
- Compulsory Annex: 'Type of Participants' (excel template), which must be uploaded as a separate document.
For Stage 2 (Full Proposal):
- Proposal template - Part A: Generated by the IT system, for general information, participant details, and overall budget.
- Proposal template - Part B - Full proposal: A separate document with a page limit of 50 pages.
- Compulsory Annex: 'Annex to the budget and type of participants' (excel template), complementing Part A budget figures with IHI-specific items.
- Compulsory Annex: 'Declaration of in-kind contribution commitment' (word document), applicable to the second stage of two-stage calls.
- Compulsory Annex: 'Essential information for clinical studies' (or a statement declaring the proposal does not include clinical studies), if applicable.
- Optional Annex: 'In-kind contributions to additional activities (IKAA)' (excel template).
- Optional Annex: 'Ethics' for additional information on serious ethics issues not covered in Part A.

Support and Guidance

Online Manual: Comprehensive guide for proposal submission and grant management.
Horizon Europe Programme Guide: Detailed guidance on the structure, budget, and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ: Answers to common questions.
Research Enquiry Service: For general questions about European research.
National Contact Points (NCPs): Provide guidance, practical information, and assistance in participating in Horizon Europe.
Enterprise Europe Network: Offers advice to businesses, especially SMEs, including on EU research funding.
IT Helpdesk: For technical support related to the Funding & Tenders Portal.
European IPR Helpdesk: Assists with intellectual property issues.
CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk: Advise on standardization in project proposals.
European Charter for Researchers and Code of Conduct: General principles for researchers, employers, and funders.
Partner Search: A tool to find partner organizations for proposals.

Evaluation Criteria

General evaluation criteria, scoring, and thresholds are detailed in Annex D of the Horizon Europe Work Programme General Annexes and the 'Conditions of the Calls for proposals and Call management rules' section of the IHI JU Work Programme. Project Quality and Methodology

Robust methodologies: Proposals must demonstrate the development of robust methodologies for establishing non-carcinogenic infection-associated non-communicable disease (NCD) causal relationships.
Comprehensive strategy: A clear strategy for assessing causal links, integrating modeling, AI-assisted data mining, appropriate statistical methods, and prioritization approaches for Mechanism of Action (MoA) studies.
Preliminary data and risk mitigation: Submission of preliminary data to demonstrate project potential, along with comprehensive strategies for mitigating methodological risks and limitations.
Technical excellence: Effective utilization of multi-omics technologies, artificial intelligence, and pre-clinical model verification.

Expected Outcomes and Impact

Accelerated interventions: Contribution to accelerating access to more cost-effective interventions for highly burdensome diseases.
Prevention and early intervention: Potential for developing vaccine strategies to prevent chronic diseases and establishing early intervention strategies that can halt or reverse chronic disease progression.
Quality of life improvement: Significant contribution to improving the quality of life for individuals through enhanced prevention and early diagnosis.
Innovation adoption: Acceleration in the adoption of innovative diagnostic, preventative, and therapeutic strategies.
Strategic alignment: Alignment with broader EU political priorities, including boosting European competitiveness and contributing to the European Health Data Space (EHDS) and the EU Artificial Intelligence Act.
Sustainability: A credible strategy for ensuring the sustainability of project outputs beyond the funding period.

Resource Allocation and Implementation

Transparency and traceability: Transparent consortium work, with clear communication of data provenance, model interpretability, traceability, and limitations, especially concerning AI modeling and decision-making.
Regulatory foresight: Consideration of potential regulatory impacts and the inclusion of a comprehensive regulatory strategy and interaction plan.
Stakeholder engagement: Anticipation of active engagement with regional healthcare systems and authorities to prepare for clinical implementation and outcome acceptance.

Cross-cutting Themes

Inclusivity in data: Prioritization of research cohorts that are diverse in ethnicity, socio-economic status, and gender representation.
Ethical compliance: Strict adherence to all ethical and data privacy standards applicable to research.

Compliance & Special Requirements

Regulatory Compliance

Projects must comply with the general conditions outlined in the Horizon Europe Work Programme General Annexes.
Strict adherence to the European Health Data Space (EHDS) Regulation (EU) 2025/327 and the EU Artificial Intelligence Act (Regulation (EU) 2024/1689) is required, as the project's impact aligns with these.
Compliance with GDPR (Regulation (EU) 2016/679 and 2018/1725) is mandatory, particularly regarding ethical and data privacy standards for research.
Applicants are expected to consider the potential regulatory impact of their results and develop a regulatory strategy and interaction plan.

Ethical Standards

Compliance with all relevant ethical and data privacy standards for research is paramount.
An ethics self-assessment must be included in Part A of the proposal. Additional ethics information can be provided in an optional annex for serious ethics issues.

Data Management and Security

Full transparency is required for consortium work, including clear communication of data provenance, model interpretability, traceability, and limitations, especially when utilizing AI modeling and decision-making.
The project's findings should align with the 'privacy by design' and 'privacy by default' principles, emphasizing strong technical and security safeguards for electronic health data.
It is prohibited to use electronic health data for measures detrimental to natural persons (e.g., increasing insurance premiums, discrimination in employment, direct advertising of products) or to attempt re-identification of individuals from provided datasets.

Project Scope Limitations

Product development is explicitly out of scope within the proposed project timeline.
The launch of new prospective cohorts is not permitted within the 5-year project timeframe; however, limited recruitment to address specific data gaps in existing cohorts may be considered.

Specific Project Requirements

The project's core objective is to identify potential causal links and biomarkers related to infection-induced NCDs, leading to detailed mechanism of action (MoA) studies.
Projects must generate robust evidence for proof of causality, moving beyond merely strengthening known associations.
Collaboration and synergy are expected with other funded projects from IHI Call 11 (e.g., 'Towards precision medicine: platform for transdiagnostic stratification of brain dysfunction') and other relevant global, European, and national initiatives.
A strategy ensuring the sustainability of the project's outputs beyond the funding period must be included in the proposal.

Grant Details