Understanding the interactions between cardiovascular disorders and comorbidities and/or their therapeutic treatments - InterHeart

Beneficiary & submission

Submission: The submission procedure will be in two steps. The submission of the pre-proposals will take place from January 7th, 2025 to March 7th, 2025 12h00 CET. For this step, the pre-proposal must be prepared in English following the ERA4Health pre-proposal template available on the ERA4Health website (https://era4health.eu/calls/interheart2025.php). The project coordinator must submit the pre-proposal on the PT-outline platform (https://ptoutline.eu/app/era4healthinterheart) and fills the different fields on the PT-outline platform before the deadline. The full proposal submission will take place from May 7th, 2025 to June 17th, 2025, 12 CEST. The consortia invited to participate to the second step must prepare their full proposal in English following the full proposal template that will be sent by the Joint Call Secretariat concomitantly with the first step results. Similarly, to the first step, the project coordinator must submit the full proposal in English and on the PT-outline platform using the same login than for the first step before the deadline. The second step will include a rebuttal phase (see below). Eligibility Criteria: Joint research proposals may be submitted by applicants belonging to one of the following categories (according to national/regional regulations; certain categories may not be eligible for funding by a specific funding organisation, please see Annex I of the call text available on ERA4Health website): ·A. Academia – research teams working in public and private universities, other higher education institutions or research institutes. ·B. Clinical/public health sector – research teams working in hospitals/public health and/or other health care settings and health organisations, including primary health care. ·C. Enterprises – private companies of all sizes involved in health research and innovation. ·D. Operational stakeholders – e.g. patient advocacy organisations, municipalities and local governments, local/national NGO’s. In line with the concept of Responsible Research and Innovation (RRI), operational stakeholders should be in a position to provide useful knowledge to the consortium, ensure that the consortium’s research is useful and translatable to their (or other) organizational contexts, and/or could (?) influence decision making or create change within their organisations. Operational stakeholders should be engaged in the research process from conception of the study to dissemination. Consortia submitting applications to this call are strongly encouraged to include partners from all the different categories (A, B, C and D) in line with the crosscutting/multidisciplinary nature of the call that aims to include partners at different levels in the value chain. The number of participants and their research contribution should be appropriate for the aims of the transnational research project, clearly demonstrating the added value of a collaborative approach. The consortium should also be well balanced in terms of international participation. It is highly recommended to integrate partners from the category B, C and D in line with the aims of the proposal. Size of the consortium: The number of participants and their research contribution should be appropriate for the aims of the transnational research project and be reasonably balanced in terms of international participation. Each transnational collaborative project should represent the critical mass to achieve ambitious scientific goals and should clearly demonstrate an added value from working together. Only transnational projects will be funded. The following conditions apply to the composition of consortia: -A minimum of 3 (three) eligible and a maximum of 5 (five) eligible partners from at least 3 (three) different countries participating in the call. -The maximum number of eligible partners can be increased up to 6 (six) or 7 (seven) if they include 1 (one) or 2 (two) partners, respectively, from the following participating countries: Latvia, Lithuania and Slovakia. -No more than 2 (two) eligible partners from the same country participating in the call will be accepted within one consortium. -A maximum of 2 (two) collaborators per consortium. Collaborators are self-funded partners who do not request funds to any of the participating funding organisations (i.e., partners from non-funding countries or partners which are not fundable according to national/regional regulations of the participating funding organisations). The following conditions apply for collaborators: -Clear added value for the research project. This should be demonstrated in the proposal. -Secure own funding for participation with clear evidence in the proposal that this is already in place. -A letter of commitment of the collaborator(s) needs to be included as an annex to the pre-proposal/ full proposal. -A collaborator cannot be work package leader. Each principal investigator can submit either 1 (one) proposal as project coordinator or up to 2 (two) proposals as simple partner (i.e. the coordinator of a proposal cannot be partner in another proposal). Please note that this rule may be subject to national/regional regulations. Applicants are consequently strongly encouraged to contact their national/regional contact points to check their national/regional eligibility rules before submission (see Annex I of the call text). Financial and legal modalities: Project partners will be funded by their relevant national/regional funding organisation. Therefore, eligible costs, funding rules and the type of studies allowed will vary between the different funding organisations. Due to these differences, it is recommended that each project partner defines its own budget in accordance with the funding rules of its own country/region. For information on the specific funding rules and eligibility criteria of the national/regional funding organization, please carefully read the Annex I of the call text (https://era4health.eu/calls/interheart2025.php). In addition, applicants are strongly advised to reach out to their relevant funding organisation contact person before applying; please, also note that for some countries/regions it might be mandatory. Evaluation: Formal check and evaluation of pre-proposals: The Joint Call Secretariat (JCS) will check all pre-proposals to ensure that they meet the call’s formal eligibility criteria (date of submission; number and category of participating countries; inclusion of all necessary information in English; appropriate limits on length). In parallel, the JCS will forward the pre-proposals to the national/regional funding organisations, which will perform an eligibility check for compliance with national/regional regulations. Each pre-proposal passing the eligibility check (JCS and country/region) will be evaluated by three reviewers for the first step evaluation (see evaluation criteria below). The reviewers will perform the assessment of the pre-proposal and complete a written evaluation form with scores and comments for each evaluation criterion. Based on the scores in the written evaluations a ranking list will be established. Potential conflicts of interests of the evaluators will be taken into consideration during the allocation of the proposals. The Call Steering Committee (CSC) members will meet to decide which pre-proposals will be invited to submit a full proposal based on the reviewers’ recommendations and to ensure a good balance of requested and available national/regional budgets. Pre-proposals which do not pass this assessment will not be invited for the full proposal stage. The consortia will receive the evaluation reports written by the 3 reviewers including advice on their RRI approach where appropriate. Formal eligibility check and evaluation of full proposals: The JCS will check the full proposals to ensure that they meet the call’s formal eligibility criteria and have not changed substantially from the respective pre-proposals before sending them to the reviewers. Each full proposal will be allocated to three reviewers taking into consideration the potential conflicts of interest. The reviewers will perform the assessment of the full proposal and complete a written evaluation form with scores and comments for each criterion. Evaluation criteria: 1. Excellence a. Scientific quality of the proposal: -Significance of the research question. -Clarity and relevance of the objectives. -Credibility and clarity of the proposed approach and methodology (including power calculations, randomisation, blinding and bias, target group(s) studied, as well as approach to RRI). -Expected progress beyond the state-of-the-art, clearly demonstrating an innovation potential. -Quality of the project consortium: international competitiveness of participants in the field(s), previous work and specific expertise of the participants, complementarity of the participants, multidisciplinary nature of the consortium, benefit of the transnational collaboration. b. Novelty and ambition (including translatability of the proposed research to human health). 2. Impact a. Unmet public and societal need and potential impact of the expected research results for future clinical, public health, and/or other socio-economic health relevant applications including patients’ needs and/or for industry (i.e., product development). b. Added value of transnational collaboration and potential for fostering international network: gathering a critical mass of patients, sharing of resources (biological material, models, databases, etc.), harmonization of data, sharing of specific know-how and/or innovative technologies, etc. c. Projects with high potential of applicability at short/medium term: expected time for market and transfer to patient towards clinical and public health applications, pharmaceutical/health device applications, other industrial applications including market and end user’s scenario, quality of dissemination, exploitation, and business plan (when appropriate/applicable). d. Participation/engagement with end-users such as patients, industry, clinicians (when appropriate/applicable). e. Effectiveness of the proposed measures to exploit and disseminate the project results (including management of intellectual property rights), to communicate the project results in a tailored manner to the different audiences (e.g., policy makers, industry, patients), and to manage research data where relevant. Please note that sub-criterion 2e will be evaluated at the full proposal evaluation stage. 3. Quality and efficiency of the implementation a. Feasibility of proposal and likelihood of successful completion of proposed research. b. Coherence and effectiveness of the work plan (including appropriateness of the allocation of tasks, resources, and timeframe). c. Use of existing biobanks and existing cohorts (when appropriate/applicable). d. Appropriateness of the management structures and procedures, including risk, innovation management and RRI and ethical considerations. e. Adequacy of the budget: appropriate distribution of resources in relation to project activities, partner’s responsibilities, and time frame. f. Sustainability of the research capacities initiated by the project (e.g., FAIR data management, Open Science practices). Quality of Intellectual Property management. Please not that sub-criterion 3e and 3f will be evaluated at the full proposal evaluation stage. Proposals not relevant to the call topic and objectives will not be funded, independently of their scientific quality. Scoring system: Each main criterion will be scored on a scale from 0 to 5.Each criterion will be scored out of five. The weight of each of the three main criteria is equal. 0 = Failure. The proposal fails to address the criterion or cannot be assessed due to missing or incomplete information. 1 = Poor. The criterion is inadequately addressed, or there are serious inherent weaknesses. 2 = Fair. The proposal broadly addresses the criterion, but there are significant weaknesses. 3 = Good. The proposal addresses the criterion well, but a number of shortcomings are present. 4 = Very Good. The proposal addresses the criterion very well, but a small number of shortcomings are present. 5 = Excellent. The proposal successfully addresses all relevant aspects of the criterion. Any shortcomings are minor. Only integer values are used. Funding thresholds: a full proposal will be considered fundable if the score for each individual criterion is at least 3 points and the overall score at least 10 points. Rebuttal stage: Before the Peer Review Panel (PRP) members meet to discuss the full proposals, each coordinator will receive the evaluation report written by the reviewers. This will allow applicants to comment on factual errors or misunderstandings that may have occurred in the review process and to reply to reviewers’ comments. However, issues not related to reviewers’ comments cannot be addressed and the work plan cannot be modified at this stage. The applicants will have 13 days for this optional response to the reviewers’ comments (August 22nd – September 3rd, 2025). PRP meeting: The JCS will give the PRP members access to full proposals, reviews, and rebuttals, avoiding any conflicts of interest. The PRP will meet to discuss each proposal and, after consideration of the evaluation criteria, reviews, rebuttal letters, and discussions, the PRP will assign final scores and rank the proposals. The final summary review report prepared by the PRP members will be sent to the respective project coordinators. Ethics clearance: After the PRP meeting, Ethics experts will remotely assess the full proposals recommended for funding by the PRP and selected for funding by the CSC, for alignment with ethics requirements and regulations[1]. A meeting will also be organised for a discussion between the various ethics experts. If necessary, the ethics experts may ask the consortium for clarifications on the ethics issues related to the proposed research approaches and for documents such as the patient consent form. The Ethics experts may highlight some points on the ethics issues that need to be monitored carefully during the implementation of the funded project in case of minor issues. Only the proposals approved by both the scientific evaluation and ethical assessment (complying with all central Horizon Europe and regional/national ethical requirements), will be funded. Decision: A final decision will be taken by the national/regional funding organisations., based on the ranking list established by the PRP, available funding and the ethics clearance., The JCS will inform the project coordinators by email of the final decision taken regarding their proposal. The projects coordinators will be responsible to communicate this information to their project partners. Redress procedure: Applicants can appeal against the evaluation outcome if they suspect a breach in the application of the evaluation and selection procedures. This redress procedure only covers the procedural aspects of the evaluation and/or central formal eligibility checks. Requests for redress on national/regional eligibility decisions will not be handled by the JCS and need to be addressed to the responsible national contact point. A mere disagreement with peer reviewers or panel members’ comments are not grounds for an appeal. The redress procedure will not call into question the scientific or technical judgement of appropriately qualified experts. In this case the applicants shall submit their appeal to the JCS via email (interheart@agencerecherche.fr) up to 7 calendar days after the date of the eligibility check or evaluation outcome email notifications by the call secretariat at the end of each step (eligibility check, first or second evaluation stage). Admissibility of appeals For an appeal to be admissible the following conditions must be met: - The appeal must be submitted by the coordinator of the proposal to which the appeal relates - Only one appeal per proposal can be submitted after each step - The appeal must be submitted via email within the 7 calendar days deadline. The appeal must contain the following minimum information: 1.The name of the call for proposals 2.   The proposal acronym 3.      The title of the proposal 4.A description of the alleged shortcomings of the evaluation procedure The appeal must demonstrate a procedural irregularity, factual or manifest errors in the evaluation process, misuse of powers, or a conflict of interests. Appeals that do not meet the above conditions, or do not deal with the evaluation of a specific proposal or express mere disagreement with the result or the reasoning of the evaluation will be judged as not suitable for redress. Upon receipt of an appeal, an acknowledgement of receipt will be sent by the call secretariat as soon as the email is read. The acknowledgement shall report the redress process and the anticipated date by which a decision on the appeal will be communicated to the appellant.   All appeals received by the 7 calendar days deadline will be processed together by a designated Redress Committee and the decision will be communicated to the appellant within 10 calendar days from the deadline for submitting the appeals. [1] Reference to EU Regulation 2021/695 and how-to-complete-your-ethics-self-assessment_en.pdf (europa.eu)