Nano and advanced technologies for disease prevention, diagnostic and therapy

Beneficiary & submission

Submission & evaluation process: Submission: The submission and evaluation procedure will be in two-steps for joint applications. The second step of the evaluation process will include a rebuttal stage. For both steps, proposals (in English) shall be prepared by the consortium partners following the ERA4Health template and must be submitted via the electronic submission system tool Pt-outline (link on ERA4Health.eu) by the project coordinator. 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 published on ERA4Health.eu): 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 provide useful knowledge to the consortium and ensure the consortium’s research is useful and translatable to their (or other) organizational contexts. Furthermore, they could contribute by influencing decision making and creating changes within their organisations. Operational stakeholders should be engaged throughout the whole duration of the research project, from the 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, whose aim is to include partners along the entire supply chain value. Only transnational projects will be funded. Size of the consortium: 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, Slovakia and Türkiye. 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: i.e., partners that 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-and full proposal. A collaborator cannot be work package leader. Each principal investigator can submit either one proposal as project coordinator or up to two proposals as simple 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. 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 (ERA4Health.eu). 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 proposals to ensure that they meet the call’s formal criteria (described in the 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 taken 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 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, 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: Evaluation scores will be awarded for the three main criteria. 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 accepted. 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 PRP members meet to discuss the full proposals in a PRP meeting, each coordinator is provided with the evaluation form produced by the reviewers. This stage allows 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 12 days for this optional response to the reviewers’ comments (23 August – 3 September 2024). 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. Ethical clearance: After the PRP meeting, ethical experts will remotely check the full proposals, which are recommended for funding by the PRP and selected for funding by the 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 during the project implementation. Only those proposals approved by both the scientific evaluation and ethical assessment 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. Project coordinators having submitted an eligible proposal will be informed about the funding recommendation regarding their proposal by the JCS. The projects coordinators are 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 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 (nanotecmec@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 step).