Research targeting development of innovative therapeutic strategies in cardiovascular disease - CARDINNOV

Open

Beneficiary & submission

SUBMISSION There will be a two-step submission and evaluation procedure for joint applications and the second review process will include a rebuttal stage. For both submission steps, one joint proposal document (in English) shall be prepared by the partners of a joint transnational proposal and must be submitted by uploading it on the electronic submission system tool Pt-outline (link on https:// ERA4Health.eu) by the project coordinator. ELIGIBLITY 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 published on https:// ERA4Health.eu): · A. Academia – research teams working in 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. · C. Enterprises – private companies of all sizes. · and D. Operational stakeholders – e.g. patient advocacy organisations, municipalities and local governments, local/national Non-Gouvernmental Organisations. 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 the consortium’s research is useful and translatable to their (or other) organizational contexts, and/or 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. Size of the consortium Only transnational projects will be funded. The following conditions apply to the composition of consortia: - Minimum of three eligible and a maximum of five eligible partners from at least three different countries participating in the call (see list above). - The maximum number of eligible partners can be increased up to six or seven (see table below) if they include one or two partners, respectively, from the following participating countries: Latvia, Lithuania, Romania, Slovakia, Turkey. - No more than two eligible partners from the same country participating in the call will be accepted within one consortium. - Maximum of two collaborators per consortium. Collaborators are self-funded partners: i.e. partners that do not request funds in this joint transnational call provided by one 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: o Clear added value for the research project. This should be demonstrated in the application. o Secure own funding for participation with clear evidence in the proposal that this is already in place. o A letter of commitment of the collaborator(s) needs to be included as an annex to the pre-proposal/ full proposal. o A collaborator cannot be work package leader. Each principal investigator can submit only one proposal as project coordinator or up to two proposals as mere partner (i.e. the coordinator of a proposal cannot be partner in another proposal). Financial and legal modalities Project partners will be funded by their relevant national/regional funding organisation. Eligible costs and funding rules vary between the respective funding organisations. The specific funding rules and eligibility criteria of the national/regional funding organization are described on Annex I of the call text (https:// ERA4Health.eu). EVALUATION Formal check and evaluation of pre-proposals The Joint Call Secretariat (JCS) will check all proposals to ensure that they meet the call’s formal criteria (described in Eligibility Criteria section) whereas each funding organisation will perform a check for compliance with national/regional regulations. Each proposal passing the eligibility check will be evaluated by three reviewers. The reviewers will perform the assessment of the pre-proposal and complete a written evaluation form with scores and comments for each evaluation criterion. Potential conflicts of interests of the evaluators will be taking into consideration during the allocation of the proposals. The Call Steering Committee (CSC; composed of one representative of each funding organisation participating to the call) members will meet to decide which proposals will be invited to submit a full proposal based on the reviewers’ recommendations and to ensure a reasonable 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. Formal check and evaluation of full proposals The JCS will check the full proposals to ensure that they meet the call’s formal 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 responsible research and innovation), · 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, 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. 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. Adequacy of the budget: appropriate distribution of resources in relation to project activities, partner’s responsibilities and time frame. e. Appropriateness of the management structures and procedures, including risk, innovation management and RRI and ethical considerations. f. Sustainability of the research capacities initiated by the project (e.g. FAIR data management, Open Science practices). Quality of the Intellectual Property management. Sub-criterion 3d, 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. Evaluation scores will be awarded for the three main criteria. Each criterion will be scored out of five. Scoring system 5 = Excellent. The proposal successfully addresses all aspects of the criterion in question. 4 = Very good. The proposal addresses the criterion very well, but small improvements are possible. 3 = Good. The proposal addresses the criterion in question well, but certain improvements are necessary 2 = Fair. The proposal generally addresses the criterion, but there are significant weaknesses that need corrections. 1 = Poor. The proposal shows serious weaknesses in relation to the criterion in question. 0 = Failure. The proposal fails to address the criterion in question or cannot be judged because of missing or incomplete information. A full proposal will be considered fundable if the threshold score for individual criterion is 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 in a PRP meeting, each coordinator is provided with the reviewers’ assessments. This stage allows applicants to comment on factual errors or misunderstandings that may have occurred in the review process and to reply to reviewers’ questions. However, issues not related to reviewers’ comments or questions cannot be addressed and the work plan cannot be modified at this stage. The applicants will have up to one week (29 August – 6 September, 2023) for this optional response to the reviewers’ comments. PRP meeting During a PRP meeting, the reviewers will discuss all proposals and produce a ranking list of proposals recommended for funding. In case of conflict of interest with a consortium, the PRP members will not be present during for the discussion about this proposal. The PRP will assign final scores, make a classification of the proposals, and rank proposals recommended for funding. The final summary review report prepared by the PRP members will be sent to the respective project coordinators. Ethical Clearance After the PRP meeting, members of the ERA4Health Ethics and RRI Advisory Board will remotely check the full proposals, which are recommended for funding by the PRP and selected for funding by CSC, for alignment with ethical norms and regulations. If necessary, tasks that need to be performed and documents that need to be submitted by the consortium will be listed. The Ethics experts may put forward additional conditions that need to be fulfilled by applicants. Only those 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, based on the ranking list established by the PRP, available funding and the ethical clearance, will be taken by the national/regional funding organisations. An external observer will be present during the PRP meeting and the funders meeting. Redress procedure The redress procedure only covers the procedural aspects of the evaluation and/or eligibility checks, including the national eligibility checks. The redress will not call into question the scientific or technical judgement of appropriately qualified experts. In this case they shall submit their appeal to the JCS via email (era4healthcall@agencerecherche.fr), up to 7 calendar days after the date of dispatch of the evaluation outcome email by the JCS at the end of each step (first or second).