Grants8 | The most comprehensive grants search on the web

Grant Analysis

Purpose & Target

This grant, HORIZON-HLTH-2025-03-DISEASE-02-two-stage, aims to advance innovative interventions for mental, behavioural, and neurodevelopmental disorders. Its core objective is to support research and innovation actions that lead to new, more effective, and safer therapeutic and relapse-preventing solutions, including those based on active substances and complementary multidisciplinary approaches. The grant explicitly targets scientific and clinical communities, encouraging participation from start-ups, micro, small, and medium-sized enterprises (SMEs), as well as broader legal entities involved in research. This is a SECTOR-SPECIFIC grant, focusing primarily on healthcare, life sciences, and related technology within the domain of brain health and mental health. The geographic scope includes EU Member States, Associated Countries (as defined by Horizon Europe Annex B), and the United States of America. Key filtering criteria for initial screening include a focus on clinical studies, novel therapeutic approaches, digital health solutions (including AI), and strong stakeholder engagement. Projects focusing on rare diseases (as defined by the EU Orphan Medicinal Products Regulation) are explicitly excluded. This grant is part of the Horizon Europe 2025 Work Programme, suggesting it is a recurring opportunity within the broader framework.

Financial Structure

This grant uses a lump sum contribution model, meaning payments are made upon the successful completion of defined work packages, rather than based on detailed reporting of actual costs incurred. This significantly simplifies financial management.

Budget Range: Individual grants are expected to be between EUR 6,000,000 and EUR 8,000,000.
Total Available Budget: The total budget for this specific topic is EUR 50,000,000 for the year 2025, expected to fund approximately 7 projects.
Eligible Costs: When proposing the lump sum amount, applicants should base their estimates on costs that would typically be eligible in an 'actual costs' grant. These include:
- Personnel costs: For employees, direct contractors, seconded staff, and SME owners/natural person beneficiaries.
- Subcontracting costs.
- Purchase costs: Such as travel and subsistence, equipment (depreciation or full capitalised costs, depending on call conditions), and other goods, works, and services.
- Other cost categories: Including financial support to third parties (if applicable), internally invoiced goods/services, and costs for transnational or virtual access to research infrastructures.
Indirect Costs: These are calculated by applying a 25% flat rate to the direct cost categories that qualify for indirect cost calculation under Horizon Europe rules. This 25% flat rate is included within the overall lump sum calculation.
Payment Mechanism: Payments are tied to the proper implementation of work packages as described in your grant agreement. If a work package's conditions are not met, that portion of the lump sum will not be paid.
Co-financing: The lump sum calculation ensures compliance with co-financing principles, meaning the total estimated costs of the action must be greater than the estimated Union contributions.
Mutual Insurance Mechanism: Between 5% and 8% of the total lump sum is retained as a contribution to the Mutual Insurance Mechanism.

Eligibility Requirements

Organizational Eligibility

Eligible Entities: Any legal entity established in EU Member States, Associated Countries (as defined in Annex B of the Work Programme General Annexes, which is not provided here), and the United States of America. This includes a broad range of scientific and clinical organizations.
SME Encouragement: The grant actively encourages the participation of start-ups, micro, small, and medium-sized enterprises (SMEs), with the aim of strengthening their scientific/technological foundations and enhancing innovation potential.
- SME Definition (from EU Recommendation 2003/361/EC):
  - Microenterprise: Fewer than 10 employees AND annual turnover not exceeding EUR 2 million OR annual balance sheet total not exceeding EUR 2 million.
  - Small enterprise: Fewer than 50 employees AND annual turnover not exceeding EUR 10 million OR annual balance sheet total not exceeding EUR 10 million.
  - Medium-sized enterprise (SME): Fewer than 250 employees AND annual turnover not exceeding EUR 50 million OR annual balance sheet total not exceeding EUR 43 million.
Financial and Operational Capacity: Requirements are described in Annex C of the Work Programme General Annexes (details not provided in the submitted documents).

Project-Specific Requirements

Scope Exclusion: Research on rare diseases (defined as affecting not more than 1 person per 2000 in the European population) is explicitly excluded from this topic.
Satellite Data Usage: If projects use satellite-based earth observation, positioning, navigation, and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS.
Security Restrictions: Entities assessed as 'high-risk suppliers' of mobile network communication equipment (and any entities they own or control) are not eligible to participate if the topic is identified as 'subject to restrictions for the protection of European communication networks' (this specific topic is not explicitly identified as such, but this is a general rule within Horizon Europe).

Application Process

Application Process This grant follows a two-stage submission process.

Submission Format: Applications must be submitted electronically via the Electronic Submission Service on the Funding & Tenders Portal.
Stage 1 - Blind Evaluation Pilot: For the first stage, applications are evaluated 'blindly'. This means your abstract and Part B of your first-stage application must not disclose your organization names, acronyms, logos, nor names of personnel.

Application Deadlines

Stage 1 Deadline: September 16, 2025, 00:00:00+0000
Stage 2 Deadline: April 16, 2026, 00:00:00+0000

Required Documentation

Standard Application Forms: You will need to use the specific application forms provided: 'Standard application form (HE RIA IA Stage 1)' and 'Standard application form (HE RIA, IA)'. These are available in the Submission System.
Clinical Studies Annex: If your proposal includes clinical studies (which is expected for this topic), applicants invited to the second stage must provide detailed information using a dedicated template provided in the submission system.

Project Implementation and Collaboration Expectations

Networking and Joint Activities: Funded projects are strongly encouraged to participate in networking and joint activities with other projects. Proposals should include a budget for attending regular joint meetings, and may consider costs for other potential joint activities, with details to be defined during the grant agreement preparation phase.
Brain Health Partnership: Projects funded under this topic should liaise with the European Partnership for Brain Health (which is covered by another topic, HORIZON-HLTH-2025-02-DISEASE-01) once it is launched.

Application Assistance and Support Various resources are available to support applicants: * Online Manual: Provides guidance on procedures from proposal submission to grant management. * Horizon Europe Programme Guide: Offers detailed guidance on the structure, budget, and political priorities of Horizon Europe. * Funding & Tenders Portal FAQ: Answers common questions on submission, evaluation, and grant management. * Research Enquiry Service: For general questions about European research and EU Research Framework Programmes. * National Contact Points (NCPs): Provide guidance, practical information, and assistance on participating in Horizon Europe, available in EU, Associated, and many non-EU/Associated countries. * Enterprise Europe Network: Offers advice for businesses, especially SMEs, including guidance on EU research funding. * IT Helpdesk: For technical support with the Funding & Tenders Portal (e.g., login, access rights, submission technicalities). * European IPR Helpdesk: Assists with intellectual property issues. * CEN-CENELEC and ETSI Research Helpdesks: Advise on standardisation in project proposals. * European Charter for Researchers and Code of Conduct: Outlines principles and requirements for researchers, employers, and funders. * Partner Search: A tool to help find partner organizations for your proposal.

Evaluation Criteria

Applications for this grant will undergo a two-stage blind evaluation pilot. Stage 1 Evaluation (Blind) In the first stage, proposals are evaluated blindly, meaning applicants must not disclose their organization names, acronyms, logos, nor names of personnel in the proposal abstract and Part B of their application.

Thresholds: Proposals must achieve a score of 4 for 'Excellence' and 4 for 'Impact'.
Overall Threshold: The cumulative score must be high enough to ensure that the total requested budget of proposals advanced to Stage 2 is as close as possible to four times (and not less than three and a half times) the available budget.

Stage 2 Evaluation For the second stage, proposals are evaluated based on three main criteria:

Thresholds: Proposals must achieve a score of 4 for 'Excellence', 4 for 'Impact', and 4 for 'Implementation'.
Cumulative Threshold: The sum of the scores across these three criteria must be 12.

Key Aspects for Evaluation (from Scope) Proposals should address most of the following aspects, which will likely contribute to scoring under the 'Excellence', 'Impact', and 'Implementation' criteria:

Clinical Studies: Demonstrate rigorous design and execution of clinical studies for safety and efficacy, ensuring adequate cohorts/sample sizes with proper representation of age, sex, and ethnicity.
Mechanism of Action Insight: Gain deeper understanding into how innovative therapies work, possibly through advanced imaging or molecular analyses, to pave the way for personalized interventions.
Technology Integration: Develop and/or use technologies, including digital ones (e.g., AI, wearable technologies), for long-term efficacy monitoring and disorder management, ensuring they are bias-free, inclusive, and ethically sound.
Data Management: Effectively exploit existing data, biobanks, registries, and cohorts, while generating new data managed according to FAIR principles (Findable, Accessible, Interoperable, Reusable).
Stakeholder Engagement: Actively involve all relevant stakeholders, especially patients, caregivers, clinicians, and regulators, using gender-sensitive and intersectional approaches.
Infrastructure Utilization: Leverage existing and emerging state-of-the-art research infrastructures (e.g., ECRIN, EATRIS, EBRAINS, BBMRI, EuroBioImaging, European Genomic Data Infrastructure) and results from previous EU-funded projects.
Regulatory Engagement: Engage with national public health authorities and regulators to ensure a robust development pathway and future uptake of the interventions.
Social Sciences and Humanities (SSH): Demonstrate effective contribution from SSH disciplines and involve SSH experts and institutions to enhance the societal impact of the research activities.

Compliance & Special Requirements

Regulatory and Ethical Compliance

General Compliance: Adherence to regulatory compliance, permits, and authorizations is expected, as outlined in Annex B of the Work Programme General Annexes (details not provided).
Ethical Standards: The grant emphasizes ethical considerations, especially for digital tools, which must be bias-free, inclusive, and ethically sound.
Data Protection and Privacy: All data generated and managed must adhere to FAIR principles (Findable, Accessible, Interoperable, Reusable), promoting open science and data sharing.
Intellectual Property (IP): IP policies are typically detailed in Annex G of the Work Programme General Annexes. Support for IP issues is available through the European IPR Helpdesk.

Technical and Project-Specific Requirements

Clinical Studies: Projects are expected to include rigorous clinical studies. Specific details regarding these studies will be required in a dedicated annex if invited to the second stage.
Digital Technologies: Strong emphasis on the development and use of digital tools, including Artificial Intelligence (AI) and wearable technologies, to implement and monitor interventions.
Research Infrastructure Utilization: Projects should leverage existing state-of-the-art research infrastructures (e.g., ECRIN, EATRIS, EBRAINS, BBMRI, EuroBioImaging, European Genomic Data Infrastructure) where applicable.

Cross-Cutting Themes and Special Considerations

Social Sciences and Humanities (SSH): The topic explicitly requires the effective contribution of SSH disciplines and the involvement of SSH experts and institutions to enhance the societal impact of research activities.
Gender and Inclusion: Clinical studies must ensure adequate representation of patient population in terms of age, sex, and ethnicity. Stakeholder engagement should apply gender-sensitive and intersectional approaches.
Innovation Focus: The core of the grant is to support 'innovative interventions' which means new and/or alternative approaches aimed at achieving a lasting therapeutic benefit, often involving a combination of active substances and multidisciplinary approaches.
Exclusion of Rare Diseases: Projects targeting rare diseases, as specifically defined by the EU, are not within the scope of this call.
Lump Sum Specifics: As a lump sum grant, the focus of controls and monitoring shifts from financial auditing to technical verification of work package completion. While no detailed cost reporting is required, the initial budget proposal must be thoroughly justified based on estimated eligible costs.
Strategic Alignment: The research supported under this topic aims to contribute to key strategic orientations of Horizon Europe, particularly towards 'A more resilient, competitive, inclusive, and democratic Europe' and reducing disease burden through improved healthcare and public health interventions.

Grant Details