Cardiovascular diseases (CVD) are the largest cause of death in the European Union (EU), as they account for around 2 million deaths per year. Overall, CVD are estimated to cause the economy of the EU costs of almost 196 billion Euros a year. Furthermore, they are one of the leading causes of long-term sickness, chronic diseases and loss to the labour market. Therefore, CVD are a major health and socioeconomic problem in Europe. Based on a better understanding of the causes of CVD, development of new innovative medicinal products and improvement in medical technology will require scientific excellence and the creation of new knowledge as drivers of future growth and prosperity. To unlock this research potential we need to better understand CVD and engage with different actors from academia, healthcare providers, industry as well as patients organizations and to shape more effective research strategies. These will ultimately lead to better preventive, therapeutic and diagnostic strategies for patients in Europe and worldwide.
However, the present and future challenges in cardiovascular research can only be met by an effective cooperation at transnational level. To achieve this goal, an effective coordination of research at national and EU level, increased cross-disciplinary interaction and research advancements are needed. In this context, the ERA-NET on Cardiovascular Diseases (ERA- CVD) has been established under the ERA-NET scheme of the European Commission (http://www.ERA-CVD.eu). The aim of ERA-CVD is to foster new but also extend existing transnational cooperation of European countries on CVD research.
Under the umbrella of ERA-CVD, a joint transnational call (JTC 2017) is now launched in the field of coronary artery disease. The following funding organisations have agreed to fund the joint call for multinational research projects in this scientific area:
Belgium, Flemish Region: Research Foundation Flanders (FWO)
Estonia: Estonian Research Council (ETAg)
France: French National Research Agency (ANR)
Germany: Federal Ministry of Education and Research (BMBF)
Israel: Chief Scientist Office of the Ministry of Health (CSO-MOH)
Italy: Italian Ministry of Health (MoH-IT)
Latvia: State Education Development Agency (VIAA)
Norway: The Research Council of Norway (RCN)
Poland: National Centre for Research and Development (NCBR)
Portugal: Ministry of Health Portugal (MS)
Romania: Autoritatea Naţională pentru Cercetare Ştiinţifică şi Inovare (ANCSI)
Slovakia: Slovak Academy of Sciences (SAS)
Spain: National Institute of Health Carlos III (ISCIII)
Taiwan: Ministry of Science and Technology (MoST)
The Netherlands: Dutch Heart Foundation (DHF)
The Netherlands: The Netherlands Organization for Health Research and Development (ZonMw)
Turkey: The Scientific and Technological Research Council of Turkey (TÜBITAK)
The call will be conducted simultaneously by the funding organisations in their respective countries and coordinated centrally by the Joint Call Secretariat.
2. AIM OF THE CALL
Coronary Artery Disease (CAD), including stable angina pectoris and acute coronary syndromes, is caused by atherosclerosis and plaque formation in the walls of the coronary arteries, which supply blood to the heart. Despite the discovery and management of many risk factors, complications of atherosclerosis remain high and are nowadays the leading cause of cardiovascular morbidity and mortality worldwide (WHO, global burden of disease). This indicates that i) additional pathophysiological mechanisms still require to be uncovered, ii) prevention can be significantly improved, and iii) efforts should be made to fill the gap between basic research and clinical practice.
ERA-CVD intends to address these challenges by a Joint Transnational Call for proposals (JTC 2017) focused on:
“Mechanisms of early atherosclerosis and/or plaque instability
in Coronary Artery Disease”
The JTC 2017 aims at enabling scientists in different countries to build an effective collaboration on common multidisciplinary research projects based on complementarities and sharing of expertise in the field of coronary artery disease, with a clear translational research approach.
Supported projects are expected to have a concrete impact in the early recognition and prognosis of CAD and will be of help at identifying those individuals /patients who will likely develop acute events in the near future (0-12 months).
Transnational research proposals must cover at least one of the following two sub-topics, which are equally relevant for this call, in relation to early recognition of CAD:
exploration of mechanisms leading to plaque instability, including the role of genetic factors, nutritional and gut microbiota giving mechanistic insights into the development, progression or plaque instability;
improvement of imaging techniques as well as validation of biomarkers (genetic, epigenetic, lipidomic, proteomic, metabolomics, microbiota), leading to earlier recognition of risk and/or protective factors. Biomarkers are characteristics that are measured as an indicator of a biological or pathological process, or of a pharmacological response. Validation studies must provide published data on the sensitivity of the biomarker in question and may apply for further specificity, bio-analytical assessment, probability of false positives or false negatives and Pharmacokinetic-Pharmacodynamic (PK-PD) model validation steps.
Additionally, each proposal should consider the following cross-sectional aspects:
• interdisciplinary approach, e.g. integrating biomedicine, physics, chemistry, mathematics, systems biology and clinical medicine for the development of the applications;
research on sex/gender differences in order to give further mechanistic insights into the development of the disease, its progression and to identify difference in treatment responses;
The research proposals should be built on an effective collaboration between the different research participants from different countries. Project proposals must clearly demonstrate the potential scientific impact as well as the added value of transnational collaboration: sharing of resources (models, databases, diagnosis etc.), harmonisation of data, sharing of specific know- how and/or innovative technologies, etc.
Each transnational collaborative project should represent the critical mass to achieve ambitious scientific goals. Consortia are encouraged to demonstrate engagement with clinics, SME or Pharma and Patient organisation for its active participation including areas of collaboration, sharing of resources, capabilities and expertise, in order to ensure an efficient transfer of pre- clinical results into clinical utility.
The following types of research projects are excluded from the call:
3. CALL IMPLEMENTATION BOARDS
The Call Steering Committee (CSC) and the Scientific Evaluation Board (SEB), will manage the evaluation process and the final selection and award of research projects, with the support of the Joint Call Secretariat (JCS).
The CSC is composed of one single representative from each national/regional funding organisation participating in ERA-CVD JTC 2017.The CSC will supervise the preparation and the implementation of the call and will take all decisions concerning the call. Based on the ranking list delivered by the SEB and on the available funding, the CSC will recommend to the national/regional funding organisations the projects to be funded. Based on these recommendations, final decisions will be made by the national/regional funding organisations.
The evaluation of the submitted proposals will be performed by a panel of internationally recognised scientific experts. At the stage of pre-proposal evaluation, external peer reviewers will contribute with written remote evaluation. The SEB will be constituted by a fraction of the group of reviewers involved in the pre-proposal evaluation step. The SEB as well as external peer reviewers will be responsible for the evaluation of the full proposals. Both the SEB members and remote reviewers will sign declarations on conflicts of interest and confidentiality. SEB and CSC members are not allowed to submit or participate in proposals within this call.
4.1 Funding recipients/Eligibility
Joint research proposals may be submitted by applicants belonging to one of the following categories depending on national/regional eligibility rules as specified in Annex 2 of the “Guidelines for applicants”:
Academic research teams (from universities or other higher education or research institutions);
Clinical/public health sector research teams (from hospitals/public health and/or other health care settings and health organisations);
Enterprise’s research teams. Participation of small and medium-size enterprises (SMEs) or industry is encouraged when allowed by national/regional regulations.
Please note that the inclusion of a non-eligible partner in a proposal may lead to the rejection of the entire proposal without further review. The individual research groups in the successful applicant consortia will be funded by the funding organisation of their country/region that is participating in the ERA-CVD JTC 2017. The applications are therefore subjected to the eligibility criteria of national/regional funding organisations. The adherence to the national/regional regulations is mandatory. Applicants should refer to the Annex 2 of the “Guidelines for applicants” for the national/regional eligibility criteria and regulations and should contact their respective national/regional funding organisation contact points for additional clarification. Each Principal Investigator (PI) - in an applicant consortium cannot participate in more than one proposal.
Please note that an eligibility check before the pre-proposal submission is mandatory for the Ministry of Health – Italy (MoH-IT).
Only applications from multinational research consortia will be considered. Each consortium should have the critical mass to achieve ambitious scientific goals and should clearly demonstrate added value of the collaborative work between the individual partners.
Only projects that fulfil the legal and ethical international/EU and national and institutional standards will be funded. Funding for this kind of projects will be dependent on a positive vote from the responsible local ethical and legal committee(s). All procedures involving human beings have to be conform with the Helsinki Declaration.
Each consortium submitting a proposal must involve a minimum of three (3) and a maximum of five (5) eligible partners.
Additionally, eligible partners must come from at least three (3) different countries participating in the call (see list above). A consortium must not involve more than one research group from the same country or region participating in the call, unless the second partner is an associated partner who secures his own funding. As an exception, two (2) research groups from Spain may be comprised in the same research consortium1.
In order to strengthen the European research area in the field of cardiovascular diseases, a wide inclusion of researchers from all the countries/regions participating in the call is encouraged, with a particular attention to research teams from Estonia, Latvia, Poland, Romania, Slovakia and Turkey. Research consortia including teams from these countries may increase the total number of eligible partners to six (6).
A consortium may include one (1) research group not eligible to the national/regional funding organisations participating in this call or from countries not involved in this call only if this group provides a demonstrable added value to the consortium. Such research group is not considered in the minimum number of three (3) partners mentioned above. At the stage of the pre- proposal submission, this group must confirm that funding for its activities in the project is already secured. The availability of the funding must be documented at the stage of full proposal submission.
Overall, a research consortium can comprise a maximum of seven (7) partners, if including one (1) partner from the above indicated countries (Estonia, Latvia, Poland, Romania, Slovakia and Turkey) and one (1) partner with own funding.
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Each research consortium must nominate a project coordinator, to be selected among the consortium partners eligible to receive funding. The project coordinator will represent the consortium externally and towards the JCS and CSC, and will be responsible for the scientific management of the project (such as controlling, reporting, intellectual property rights issues,
etc.). Each project partner will be represented by a single principal investigator, who will be the contact person for the respective national/regional funding organisation.
The duration of the projects can be up to 3 years. Nevertheless, a research group can receive funding for less than 3 years according to eligibility criteria and regulations of the funding organizations participating in the ERA-CVD JTC 2017.
4.2 Submission of joint proposals
ERA-CVD will be implemented through a two-stage submission procedure: pre-proposals and full proposals. Both pre- and full proposals must be written in English and must be submitted to the JCS by the coordinator through the electronic submission system PT- Outline exclusively. https://secure.pt-dlr.de/ptoutline/app/eracvd_jtc2017
In preparing the proposals, applicants should strictly follow the rules described in this call text and in the “Guidelines for Applicants”, and use the application forms available from the ERA- CVD website (www.ERA-CVD.eu).
Applicants should take note of individual national/regional rules, and contact their national/regional contact points for specific questions. The pre-proposals must be submitted to the electronic submission system no later than 6 March 2017 at 16:00 CET. The information relating to the pre-proposals selected for full proposal submission will be communicated to the coordinators by 16 May 2017. The information given in the pre-proposal is binding.
Thus, any substantial changes between the pre-proposal and the full proposals (e.g. composition of the consortia, objectives of the project, budget requested, etc.) must be communicated in advance to the JCS with detailed justification and will only be allowed by the CSC under exceptional circumstances.
The full proposals will have to be submitted to the electronic submission system not later than 23 June 2017 at 16:00 CET. Please note that full proposals will only be accepted from applicants explicitly invited by the JCS to submit them. The decision on the funding of the full proposals will be communicated to all the (successful and unsuccessful) coordinators in October 2017.
5.1 Evaluation criteria
Pre-proposals and full proposals will be assessed according to the following evaluation criteria.
Clarity and pertinence of the objectives
Credibility of the proposed approach and methodology
Soundness of the concept
Potential of the expected results for future clinical, public health and/or other socio-economic health relevant applications including patients’ needs
Added-value of transnational collaboration: gathering a critical mass of patients/biological material, sharing of resources (models, databases, diagnosis etc.), harmonization of data, sharing of specific know-how and/or innovative technologies, etc.
Effectiveness of the proposed measures to exploit and disseminate the project results (including management of intellectual property rights -IPR), to communicate the project, and to manage research data where relevant
Industry and Patient Organization participation/engagement (when appropriate/applicable)
3 Quality and efficiency of the implementation
Coherence and effectiveness of the work plan, including appropriateness of the allocation of tasks, resources and time-frame
Complementarity of the participants within the consortium
Appropriateness of the management structures and procedures, including risk
and innovation management
Budget and cost-effectiveness of the project (rational distribution of resources in relation to project’s activities, partners responsibilities and time frame)
Sub-criteria 2d, 3c and 3d will mainly be taken into account for the full proposal evaluation step.
5.2.1 Range and interpretation of the scores
A scoring system from 0 to 5 will be used to evaluate the proposal’s performance with respect to each of the three evaluation criteria, as follows:
0: Failure. The proposal fails to address the criterion in question, or cannot be judged because of missing of incomplete information.
1: Poor. The proposal shows serious weaknesses in relation to the criterion in question.
2: Fair. The proposal generally addresses the criterion, but there are significant weaknesses.
3: Good. The proposal addresses the criterion in question well but improvements are necessary.
4: Very good. The proposal addresses the criterion very well but small improvements are possible.
5: Excellent. The proposal successfully addresses all aspects of the criterion in question.
Evaluation scores will be awarded for the 3 main criteria, and not singularly for the different aspects listed below the criteria. Each criterion will be scored out of 5. The threshold for individual criteria will be 3. The overall threshold, applying to the sum of the three individual scores, will be 12. The maximum score that can be reached from all three criteria together is 15 points.
In the evaluation of proposed research projects, special attention will be reserved for potential ethical issues (e.g. research on humans, animals or biomaterials including stem cells). Only projects that fulfil the legal and ethical International, EU, National and Institutional regulations and standards will be funded.
It is a contractual obligation of ERA-CVD partners to ensure the confidentiality of information and documents obtained during the evaluation and the selection procedures of the joint transnational call. Please note that half-marks may be given.
5.3 Eligibility check of pre-proposals and first step peer review
5.3.1 Eligibility check
The JCS will examine all pre-proposals to ensure that they meet the formal criteria of the call (date of submission, number and country distribution of participating research partners, inclusion of all necessary information in English, adherence to the application forms, document length). The JCS will forward the proposals to the CSC members who will perform a check for compliance with national/regional regulations as described in the Annex 2 of the “Guidelines for applicants”.
Please note that proposals not meeting the formal criteria or the national/regional eligibility criteria and requirements may be declined without further review.
After completion of the eligibility check, the CSC will take the final decision; the pre-proposals not considered eligible will be rejected without further review. The coordinators of the non- eligible pre-proposals will be informed accordingly by the JCS.
5.3.2 Evaluation of pre-proposals
Pre-proposals passing the formal eligibility check as described in section 5.3.1 will be forwarded to the external reviewers for evaluation, based on the evaluation criteria described in section 5.1. Each pre-proposal will be assessed by three (3) reviewers.
The tentative number of proposals that will be invited for a full proposal submission will be approximately three times the number of projects that may be funded and will depend on where a break is perceptible in the quality of proposals. All applicants will receive feedback on their proposal after the review process of pre-proposal. Successful applicants will be invited by the JCS to submit a full proposal.
5.4 Eligibility check of full proposals and second step of evaluation
5.4.1 Formal criteria check
The JCS will check the full proposals to ensure that they meet the formal criteria of the call (date of submission, number and country distribution of participating research partners, inclusion of all necessary information in English and length) and have not changed substantially from the respective pre-proposals. A full proposal may be excluded from further review if formal criteria are not met or the composition of the consortium deviate substantially from the previously submitted pre-proposal. In any case, major changes must be communicated in advance to the JCS, which will contact the concerned national/regional funding organisation to discuss the issue; a formal decision on whether such an exceptional change may be justified will be taken by the CSC.
5.4.2 Evaluation by SEB and external reviewers
Each full proposal will be allocated to at least two (2) SEB members, and at least two (2) external reviewers. One of the SEB members will be appointed as rapporteur. The SEB members and the external remote reviewers will independently assess the full proposals according to the evaluation criteria mentioned above.
5.4.3 Rebuttal stage
Once the evaluations of full proposals are completed, each proposal coordinator will receive an anonymous evaluation report (without the assigned scores). At this stage coordinators are allowed to reply to ‘reviewers’ questions and to comment on factual errors or misunderstandings on the evaluations. However, issues which are not related with ‘reviewers’ comments or questions cannot be addressed and the work plan cannot be modified. The resubmission of the full proposal is not permitted in any case.
The rebuttal to reviewers’ comments is optional and must be submitted exclusively by the coordinator of the proposal to JCS, which will be available from the 14 August 2017 to the 21 August 2017 at 16:00 (Central European Summer Time, CET).
5.4.4 Ranking of the full proposals
In preparation of the SEB panel meeting, all SEB members will get access to the assigned reports and to the optional responses submitted by the coordinators following the rebuttal stage. During the SEB panel face-to-face meeting, each full proposal will be presented by the rapporteur and discussed by the SEB members on the basis of the individual evaluation reports and rebuttals so as to reach consensus scoring. As a result of these discussions and as an outcome of the SEB meeting, a ranking list of the full proposals will be established.
5.5 Funding decision
Based on the ranking list established by the SEB, the CSC will decide on the projects to be suggested for funding by the national/regional funding organisations.
If necessary, the CSC will determine a priority order for proposals, which have been awarded the same score within the ranking list. The following approach will be applied successively for every group of ex aequo proposals requiring prioritisation, starting with the highest scored group, and continuing in descending order:
Availability of national funding;
Maximisation of use of national funding.
The Joint Call Secretariat will communicate to all project coordinators the final decision on the approval for funding of the respective proposal together with the final evaluation report from the SEB.
6. FINANCIAL AND LEGAL ISSUES
6.1 Funding model and funding details
The ERA-CVD JTC 2017 funding partners have agreed to use the “virtual common pot” funding mode. This means that funding will be made available by each national/regional funding organisation according to its national/regional regulations, for research groups in its country/region.
Therefore, each country/region funds only its national/regional component of the transnational research project. Eligible costs and funding rates may vary according to the regulations of the individual national/regional funding organisation. Prior to submitting a proposal, applicants should verify the funding rules of the respective national/regional funding organisation (see Annex 2 of the “Guidelines for applicants”) and are recommended to ask for clarification to the corresponding contact person (see national/regional contact details in Annex I).
The coordinators will be asked to present the results of their projects at an intermediate and/or a final ERA-CVD symposium. Project proposal budget should foresee expenses for the participation of coordinators and/or national/regional research partners to an intermediate and/or a final ERA-CVD symposium. Travel expenses for young scientists (PhD students, postdocs,
young PIs2) involved in the proposal and willing to join young scientist activities organized by ERA-CVD should be foreseen. It is recommended to check the national/regional funding regulations on costs eligibility with the respective national/regional funding organisations. Funding is granted for a maximum of three years according to national/regional regulations.
6.2 Funding contracts
Each project includes several consortium members called research partners and one project coordinator. Each research partner (including the project coordinator) will receive a separate funding contract/letter of grant according to national/regional regulations from the appropriate national/regional funding organisation.
Changes within the composition of research consortia or in budget cannot occur during the contract/letter of grant, unless there is a good justification. Any minor changes have to be well justified and the relevant funding organisations will decide upon the proper action to be taken. However, in case of major changes, an independent expert can be consulted to help with the final decision of the funding organisations. The coordinator shall inform the JCS of any event that might affect the implementation of the project. The JCS will transfer the information to the relevant funding bodies.
Depending on the time needed for the administration of granting funds to the respective national/regional research groups, individual projects of a research consortium are expected to start by April 2018. The official start date shall be communicated by the project coordinator to the JCS and shall appear in the consortium agreement established in accordance to section 6.3 below.
6.3 Research consortium agreement, ownership of intellectual property rights, ethical issues
The members of a funded research project consortium must sign a Consortium Agreement (CA) addressing the issues indicated in the section of the “Guidelines for applicants” on consortium agreements, including Intellectual Property Rights (IPR) issues. The consortium members are strongly encouraged to sign this CA before the official project start date. In any case the CA has to be signed no later than six months after the official project start date. Please note that national/regional regulations may apply concerning the requirement for a CA. The consortium members are strongly advised to check the country/region-specific information in the “Guidelines for applicants” and/or to contact the respective national/regional contact point. Upon request, the CA must be made available to the concerned ERA-CVD JTC 2017 funding organisations.
Results and new IPR resulting from projects funded through the ERA-CVD JTC 2017 will be owned by the relevant research organisations according to international/national/regional rules on IPR. If several participants have jointly carried out work generating new IPR, they shall agree amongst themselves (i.e. in the CA) on the allocation of ownership of IPR, taking into account their contributions to the creation of the new IPR as well as the European guidelines on IPR issues.
The results of the research project and IPR created should be actively exploited and made available for use, whether for commercial purpose or not, in order for public benefit to be obtained from the knowledge created.
The ERA-CVD JTC 2017 funding organisations shall have the right to use documents, information and results submitted by the research partners and/or to use the information and results for their own purposes, provided that the owners’ rights are kept and their origin is specified.
Any ethical issues should be addressed at the proposal submission stage, and subsequent authorization presented at the latest, and upon request by the national/regional funding organisations, before the process of grant negotiation.
6.4 Confidentiality of proposals
Proposals and any relating information shall be kept confidential by the SEB members, the external reviewers and the CSC members. Proposals shall not be used for any purpose other than the evaluation and subsequent monitoring of the funded projects.
Full proposals will be required to include a publishable summary, which will clearly identify the main goals of the project. All other project details shall remain strictly confidential.
7. REPORTING AND DISSEMINATION
The coordinators of all the funded projects must submit annual scientific project reports (annual report to be submitted within two months after the end of each year; the reference date being the common project start date stated in the Consortium Agreement ) and a final scientific project report (submitted within two months of the end of the project) to the JCS JTC 2017 MoH-IT, Italy. All reports must be written in English and comply with the reporting templates (one for the annual reports and one for the final report) that will be provided to the coordinators of the funded projects in due time. In addition the reports will include a monitoring questionnaire to be used to assess the achievements of the funded projects. The research partners are jointly responsible for delivery of the reports, and only reports delivered on behalf of the consortium, via the project coordinator, will be accepted.
In addition to these centrally-administered ERA-CVD JTC 2017 reports, principal investigators may be requested to submit financial and/or scientific reports to their national/regional funding organisations, according to national/regional regulations.
The progress and final results of each individual contract/letter of grant will be monitored by the respective national/regional funding organisations. In case of serious difficulties in the conduct of the research project, the coordinator shall promptly inform the JCS and the relevant funding organisations. These funding organisations will decide upon the proper actions to be taken. The coordinators and/or national/regional research partners will be asked to present the results of their projects at an intermediate and/or a final ERA-CVD symposium.
Furthermore, funding recipients are asked to provide information about their funded project to the project database CardioScape (www.cardioscape.eu). Details about the relevant information needed will be provided by a CardioScape contact person.
ERA-CVD follows an open-access policy. Funded research partners should consider Open Access publication of their results. For communication purposes, coordinators of the funded projects are required to submit periodic concise lay term summaries of the projects. The first summary will be provided upon receipt of funding decision and will include a lay term summary and appropriate figures.
Funding recipients must ensure that all outcomes (publications, etc.) arising from the transnational project include a proper acknowledgement that the project is supported by the respective national/regional funding organisations and, collectively, by the national funding organisations under the framework of the ERA-NET ERA-CVD initiative.
8. CONTACT AND FURTHER INFORMATION
The JCS is set up at Ministero della Salute (MoH-IT), Italy. The JCS will assist the CSC and the national/regional funding organisations during the implementation of the call.
The JCS JTC2017 MoH-IT will be responsible for the follow-up phase until the funded research projects have ended. The JCS will be responsible for the administrative management of the call evaluation. It will be the primary contact referring to the ERA-CVD JTC 2017 procedures towards the research consortia, the funding organisations (CSC) and the peer reviewers (SEB members and external experts).The project coordinator will be the person contacted by the JCS during the application procedure, and must forward this information to the other participants.
Further information on the ERA-CVD project, the ERA-CVD JTC 2017 and its planned time schedule is available at the ERA-CVD website: www.ERA-CVD.eu. Before submitting a proposal, applicants are strongly advised to contact their national/regional funding organisations for national/regional specific regulations (see contact details in Annex I).
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