Call text of the 2021 “Neurodevelopmental Disorders” call

Note: This call is already closed

Call for Proposals for Transnational Research Projects on Neurodevelopmental Disorders

1. Purpose

Maintenance, improvement, and restoration of human health are of fundamental importance and a worldwide priority. Neurological and mental disorders are major causes of morbidity and, meas-ured in Disability Adjusted Life Years (DALYS), account for 413.1 million DALYs globally. In Eu-rope, people suffering from these conditions amount to 380 million. This not only imposes a high societal but also a major economic burden to the European population, leading to costs of more than 800 billion euros per year. A wide range of brain disorders already manifests during devel-opment in early life. Such neurodevelopmental disorders severely curtail the quality of life of pa-tients and their families often throughout their entire lifespan. Thus, neuroscientific research on neurodevelopmental disorders and its translation into diagnostic and therapeutic outcomes is a central pillar to promote healthy living in Europe and worldwide.

The 'Network of European Funding for Neuroscience Research' (NEURON) has been established under the ERA-NET scheme of the European Commission (www.neuron-eranet.eu). The aim of the ERA-NET NEURON is to coordinate and optimize research efforts and funding programmes of its partner countries in the field of mental, neurological and sensory disorders. Under the umbrella of NEURON, a joint transnational call (JTC 2021) in the field of neurodevelopmental disorders is now launched together with the European Commission using the ERA-NET co-fund mechanism. The following funding organisations have agreed to fund the joint call for multinational research projects in this scientific area. The call will be conducted simultaneously by the funding organisa-tions in their respective countries and co-ordinated centrally by the Joint Call Secretariat.

• Fonds de la Recherche Scientifique-FNRS (F.R.S.-FNRS) - Belgium*
• Research Foundation – Flanders (FWO) - Belgium
• Ministarstvo Znanosti i Obrazovanja (MZO) - Croatia
• Estonian Research Council (ETAg) - Estonia
• Suomen Akatemia (AKA) - Finland
• French National Research Agency (ANR) - France
• Federal Ministry of Education and Research (BMBF) - Germany
• National Research, Development and Innovation Office (NKFIH) - Hungary
• Health Research Board (HRB) - Ireland
• Chief Scientist Office, Ministry of Health (CSO-MOH) - Israel
• Ministry of Health (MOH) - Italy*
• State Education Development Agency (VIAA) - Latvia
• The Research Council of Norway (RCN) - Norway
• National Centre for Research and Development (NCBR) - Poland
• Foundation for Science and Technology (FCT) - Portugal
• Executive Agency for Higher Education, Research, Development & Innovation Funding (UEFISCDI) - Romania
• Slovak Academy of Sciences (SAS) - Slovakia
• National Institute of Health Carlos III (ISCIII) - Spain
• Spanish State Research Agency (AEI) - Spain
• Swiss National Science Foundation (SNSF) - Switzerland*
• Ministry of Science and Technology (MOST) - Taiwan
• The Scientific and Technological Research Council of Turkey (TUBITAK) - Turkey*

* Countries with parallel national application procedures. We strongly recommend to contact the respective funding organisation for further information (contacts, see Annex I).

2. Aim and scope of the call

The aim of the call is to facilitate multinational, collaborative research projects that will address important translational questions relating to the neurodevelopmental nature of neurological and mental disorders. Neurodevelopmental disorders are behavioural and cognitive disorders that arise during the developmental period that involve significant difficulties in the acquisition and execution of specific intellectual, motor, or social functions^[1]. This call is limited to disorders, which show their first manifestations before the end of adolescence and impair the development and the function of the nervous system. Research on the continuation or progression of those symptoms with a lifetime perspective is allowed if addressing the consequences of disorders starting before adolescence. Research areas may cover a broad range of aspects associated with neurodevelopmental disorders, e.g. genetics, epigenetics, molecular mechanism of disease, neural circuits implicated in the pathophysiology, the relevance of prenatal and environmental factors including ‘in utero’ environment, the role of non-neuronal cells, resilience factors, or the development of treatments or diagnostic approaches specific for the developing nervous system or paediatric populations, including digital health innovations as well as other cross-sectional aspects of these diseases. The call will accept research proposals ranging from understanding basic mechanisms of neurodevelopmental disorders through proof-of-concept clinical studies in humans.

The NEURON funding organisations particularly wish to promote interdisciplinary work and translational research proposals that combine basic and clinical approaches. In the context of the present call, the collaboration across different disciplines including both clinicians and fundamental neuroscientists is highly encouraged. The consortia are expected to submit novel, ambitious ideas that can only be achieved by the complementary collaboration between partners.

Research proposals should cover at least one of the following areas:

a) Fundamental research addressing the pathogenesis, aetiology, susceptibility, and resilience mechanisms of neurodevelopmental disorders. This may include the development of innovative or shared resources and technologies that are relevant for neurodevelopmental disorders.

b) Clinical research to develop novel strategies for prevention, diagnosis, patient stratification, therapy and/or rehabilitation for neurodevelopmental disorders.

Clinical studies are eligible up to the point of proof of concept^[2]. The establishment of large patient cohorts will not be funded by NEURON, but the use of existing cohorts, brain banks and exploitation of existing data sets are encouraged. Appropriate access to relevant, well-characterized patient populations or suitable biomaterial collections must be demonstrated. Applicants should demonstrate that they have the expertise and range of skills required to conduct the study, or that appropriate collaborations are in place. The development of new animal or cell models is only allowed if an appropriate model is not available and must be justified. The consideration of gender differences in the studies is mandatory. If relevant, it is recommended that the appropriate European infrastructures are contacted early in the planning of the projects, in particular EATRIS-ERIC (focused on translational medicine), BBMRI-ERIC (focused on biobanking) and ELIXIR (focused on data sharing). Different platforms can be found via the European Strategy Forum for Research Infrastructures in Europe - ESFRI (www.esfri.eu).

The following research areas are excluded from this call:

• Neurodegenerative disorders that are addressed by the EU Joint Programme - Neurodegenerative Disease Research (JPND)^[3].    

he ERA-NET NEURON seeks to strengthen patient engagement in research. Applicants are expected to engage patients, their parents or carers where appropriate in the research process. Meaningful patient engagement can occur at the level of research planning, conducting research or the dissemination of research results. Patient representatives will participate in the review of selected full-proposals and provide feedback on patient engagement aspects. All applications should include a description of expected outcomes with potential relevance for patients.

3. Application

3.1 Eligibility

Joint transnational research proposals may be submitted by research teams working in universities (or other higher education institutions), non-university public or private research organisations, hospitals or foundations, as well as in commercial companies, particularly small and medium-size enterprises^[4]. The eligibility of the afore-mentioned institutions, together with details of eligible costs (e.g. personnel, material, consumables, travel money, investments), are subject to the administrative requirements of individual funding organisations and will therefore differ. Please note that, for some funding organisations, commercial companies are not eligible or are only eligible under certain conditions (e.g. only in partnership with academic institutions in the consortium). Clarification should be obtained from the individual funding organisations (see contact details below). It is strongly recommended to read carefully the country specific information regarding eligibility and funding and to contact the respective funding organisations, since additional national/regional procedures might be obligatory.

Only transnational projects will be funded. Each consortium submitting a proposal must be comprised of a minimum of three research partners eligible for funding by organisations listed in this call text (see above). The eligible research partner must be from at least three different participating countries. The total number of research partners in a consortium is limited to five, including partners participating with their own expenses. No more than two consortium partners can be from the same country.

The ERA-NET NEURON strives to strengthen a global Brain Research Area by including as many partner countries as possible in its funding scheme. Therefore, consortia including at least one partner from countries that are to date underrepresented in this funding scheme (Latvia, Hungary, Romania, Turkey, and Slovakia) may increase the total number of partners to six.

Applicant partners, which are not eligible for funding from their national funding organisations or from countries that are not involved in this call, may participate in projects only if their participation clearly provides an added value to the consortium, and if they present evidence on secured budget for their part in the project. Such potential partners are not considered in the minimum number of three research partners mentioned above. In any case, the total number of research partners in one consortium must not exceed five, or six, if partners from the underrepresented countries listed above are included.

Each consortium should have the critical mass to achieve ambitious scientific goals and should clearly demonstrate added value from working together. Each project must nominate a project coordinator who represents the consortium externally and is responsible for its internal management (e.g. the application procedure, coordination of consortium agreement drafting, Data Management Plan, reporting). The consortium coordinator must be eligible for funding by one of the organisations listed in this call text.

A single proposal must be submitted by the consortium coordinator to the NEURON Joint Call Secretariat. The individual research partners in a consortium will be funded by the NEURON funding organisation(s) of their respective countries. Eligibility criteria are the matter of individual partner funding organisations and additional national/regional regulations and requirements may apply.

Inclusion of a partner in a proposal that is not eligible for funding according to the specific regulations of its respective funding organisation may result in the rejection of the entire proposal without further review. Therefore, applicants are strongly advised to follow the instructions contained in the country-specific eligibility tables, which are published on the NEURON website and to contact their national/regional funding organisation to confirm eligibility before submitting an application.

Only projects that fulfil the legal and ethical international/EU (including ethical standards and guidelines in Horizon 2020) as well as national and institutional standards will be funded. All proposed activities including those undertaken in countries outside the EU must comply with EU regulations (see Annex I of the full-proposal). Ethical approval and/or a positive vote must be obtained from the relevant national or local ethics committee(s) prior to the start of respective studies. The obtainment of ethical clearance will be queried within the annual reports. All procedures involving human beings should conform to the Helsinki Declaration.

3.2 Submission of joint transnational proposals

There will be a two-stage procedure for joint applications: pre-proposals and full proposals. In both cases, one joint proposal document (in English) shall be prepared by the partners of a joint transnational proposal, and must be submitted to the Joint Call Secretariat by one spokesperson, the coordinator.

Pre-proposals must be submitted in electronic format no later than 09 March, 2021 (14:00 CET) via the electronic submission system. All fields must be completed using DIN-A4; font: Arial, 10pt; single-spaced, page limits. Pre-proposals that do not meet the formal criteria will be rejected from the call process without any further review.

NOTE: Full proposals submissions will be accepted only from those applicants explicitly invited by the Joint Call Secretariat.

The information given in the pre-proposal is binding. Thus, any fundamental changes between the pre- and full proposals stages concerning the composition of the consortia, objectives of the project or requested budget must be communicated to the Joint Call Secretariat and the respective funding organisations with detailed justifications, and will only be allowed in exceptional cases by the Call Steering Committee, before passing to the evaluation stage.

3.3 Further information

For further details, please refer to the respective submission forms available through the NEURON web site. If you need additional information, please contact the Joint Call Secretariat. Finally, national organisations may set special requirements for their applicants. Applicants are, therefore, strongly advised to review the instructions contained in the country-specific information that are published on the NEURON website and to contact their national/regional funding organisation for further information (see Annex I for contact details).

4. Evaluation and decision

The review process will be in two stages.

4.1 Formal check of pre- and full proposals

The Joint Call Secretariat will check the proposals to ensure that they meet the call’s formal criteria (e.g. date of submission; number of participating countries; inclusion of all necessary information according to the respective templates in English). The Joint Call Secretariat will also forward the proposals to the national/regional funding organisations, which will perform a formal and eligibility check of compliance with their respective regulations.

The Joint Call Secretariat and national/regional funding organisations will perform cross-checks in parallel submissions to other joint transnational calls (e.g. EJP RD, JPND, EuroNanoMed, ERAPerMed and others) and national calls. Applicants shall avoid applying for the same research activities to different calls. Double funding is not allowed.

Proposals not meeting the formal criteria described above will be rejected at this stage. Proposals passing this step will be forwarded to the joint Peer Review Panel for evaluation.

4.2 Peer-review of pre- and full proposals

The reviewers will first assess if the projects are within the scope of the call and then, they will carry out the evaluation according to specific evaluation criteria:

1. Excellence
   • Scientific quality of the approach and methodology
   • Quality of the experimental design and data analysis
   • Novelty of the scientific concept/hypotheses
   • Competence and experience of participating research partners in the field(s) of the proposal (previous work in the field, specific technical expertise)
2. Impact
   • Potential impact of the expected results on clinical and other health related applications
   • Added-value of transnational collaboration
3. Quality and efficiency of the implementation
   • Feasibility of the project
   • Coherence and effectiveness of the work plan, including appropriateness of the allocation of tasks, resources, time-frame and related risk analysis
   • Quality and added-value of collaborative and multi-disciplinary interactions within the consortium
   • Appropriateness of the management structures and procedures

4.3 Decision

4.3.1 Pre-proposals

Eligible pre-proposals will be reviewed using the above mentioned evaluation criteria via a written (remote) peer review process. Preferably, each pre-proposal will be reviewed by at least three reviewers. Based on the scores in the written reviews a ranking list will be established. By mid-May 2021, the coordinators of the selected proposals will be invited by the Joint Call Secretariat to submit a full proposal before 30^th June 2021 (14:00 CET).

4.3.2 Full proposals

The international Peer Review Panel will evaluate the full proposals based on the above mentioned evaluation criteria and establish a ranking list of the fundable proposals based on scientific assessment at the panel meeting. Additionally, expert patient reviewers will review the patient relevant aspects of the full-proposals and an Ethics board will give recommendations on the ethical aspects of the full-proposals. Based on the ranking list the Call Steering Committee will determine the projects to be funded, taking into account the national budgets available. Based on these recommendations, final decisions will be made by the funding organisations and will be subject to budgetary considerations.

5. Funding procedure / Responsibilities / Reporting requirements

5.1 Funding procedure

Successful research groups will be funded directly by the respective funding organisations.

Funding is expected to start between the end of 2021 and the second semester of 2022[5]. Projects should be designed to be achievable during a maximum funding period of three years.

Funding will be administered according to the terms and conditions of the responsible funding organisations, taking into account all other applicable regulations and legal requirements.

5.2 Responsibilities

Within a joint proposal, each project partner will be the contact person for the respective national/regional funding organisation. The coordinators of funded projects together with the relevant funding organisations shall make every effort to seek a common start date for all research groups in the consortium.

After the evaluation and selection procedures are completed, each consortium selected to be funded is required to draft a Consortium Agreement (CA) and a data management plan (DMP). The CA will determine a common project start date, manage the delivery of project activities, finances and intellectual property rights (IPR), and avoid disputes that might be detrimental to the completion of the project. With the first annual report the coordinator must provide the DMP and the signed CA by all parties to the Joint Call Secretariat. Please note that additional national rules might require the documents before the start of the project to release funds.

5.3 Reporting Requirements

On behalf of the research consortium, the project coordinator will be required to submit to the Joint Call Secretariat annual scientific progress reports, as well as a final report at the end of the project. Additionally, the individual partners may be required to submit reports separately to their national funding organisation. In that case, reporting guidance will be forwarded by the relevant funding organisation, as applicable.

Annual reports must be submitted by April, 30, starting in 2023. Final reports must be submitted at the latest three months after the end of the project. Annual reports do not need to be submitted if the project ends between January and March on the last year. In the latter case, the submission of a final report three months after the end of the project will suffice.

It is the task of the coordinators to determine, in agreement with the consortia, a formal end date for project completion. This is required, as partners may be granted runtimes of different start and/or duration. Coordinators will be informed about this procedure by the Joint Call Secretariat and will receive the report templates in due course.

The coordinators will be asked to present a progress report during an intermediate status symposium. The attendance is mandatory for all coordinators and project partners. Failure to comply with this requirement may result in administrative and/or financial sanctions according to the rules of each funding organisation. Early-career researchers working on the projects are welcomed to join the intermediate symposium. Accordingly, travel expenses to attend the symposium should be considered in the proposal budget plans.

Funding recipients must ensure that all outcomes (publications, etc.) of transnational NEURON projects include a proper acknowledgement of ERA-NET NEURON and the respective funding partner organisations. All the publications resulting from funded projects must be published in adherence to the EC Open Science Policy.

5.4 General data protection regulation

Applicants are informed that their personal data submitted in their application to the co-funded call are processed in accordance with article 6.1 (e) and (c) of the General Data Protection Regulation (GDPR) (2016/679)[6], and for the purposes of

• processing and evaluating the application where processing shall be lawful only if and to the extent that processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;
• administering any subsequent funding award;
• managing the funding organisations relationship with them;
• analysing and evaluating the call;
• providing aggregate data to national and European surveys and analyses on the funded projects; and
• complying with audits that may be initiated by the funding organisations and the European Commission (or its agencies).

The Call Steering Committee may share applicant’s data with third parties (some of which may be based outside the European Economic Area[7],[8]) in relation to the above activities including evaluators, auditors and the European Commission (or its agencies).

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Annex I. Contact details

Please note that country specific requirements might apply to this call. Compliance with the national/regional regulations specified in the country specific information is mandatory. A parallel national application may be requested by certain countries (e.g. Belgium F.R.S.-FNRS, Italy, Switzerland, and Turkey). We strongly advise you to contact your national/regional representative prior to submitting a pre-proposal:

Country (region)	Contact person(s)	Funding organisations contact Details
Belgium (French Speaking Community)	Dr Florence Quist Joël Groeneveld	Fonds de la Recherche Scientifique – FNRS (F.R.S.-FNRS) florence.quist@frs-fnrs.be joel.groeneveld@frs-fnrs.be +32(0)2 504 93 51 +32(0)2 504 92 70
Belgium (Flanders)	Toon Monbaliu	Research Foundation - Flanders (FWO) www.fwo.be eranet@fwo.be +32 2 550 15 70
Croatia	Mirela Čokešić	Ministarstvo Znanosti i Obrazovanja (MZO) Directorate for Science and Technology Mirela.Cokesic@mzo.hr+38514594209
Estonia	Argo Soon	Estonian Research Council (ETAg) Argo.Soon@etag.ee +372 730 0372
Finland	Salo Aki	Suomen Akatemia (AKA) aki.salo@aka.fi +358 29 533 5104
France	Dr Sheyla Mejia-Gervacio	French National Research Agency (ANR)Health & Biology Department Sheyla.mejia@anr.fr +33 178 09 80 14
Germany	Dr Christina Müller	Project Management Agency (DLR-PT) – Health, on behalf of the Federal Ministry of Education and Research (BMBF) Chr.mueller@dlr.de +49 228 3821 2182 www.gesundheitsforschung-bmbf.de
Hungary	Dr Klara Horvath	National Research, Development and Innovation Office (NKFIH) klara.horvath@nkfih.gov.hu +36 1 896 3748
Ireland	Ms Louise Drudy	Health research board (HRB) www.hrb.ie LDrudy@hrb.ie
Israel	Dr Liron Even-Faitelson	Chief Scientist Office - Ministry of Health (CSO-MOH) http://www.health.gov.il/Subjects/research/International_cooperations/Pages/default.aspx liron.ef@moh.gov.il 972-2-508-2168
Italy	Dr Gaetano Guglielmi	Ministero della Salute g.guglielmi@sanita.it http://www.salute.gov.it/portale/home.html
Latvia	Dr Uldis Berkis	State Education Development Agency
		www.viaa.gov.lv Uldis.Berkis@viaa.gov.lv Office: +371-67785406 Mobile: +371-29472349
Norway	Dr Alexandra Bjørk-Skaflestad	The Research Council of Norway (RCN) alb@rcn.no +47 22 03 72 24
Poland	Dr Marcin Chmielewski	National Centre for Research and Development (NCBR)Department for international cooperation marcin.chmielewski@ncbr.gov.pl +48 22 39 07 109 www.ncbr.gov.pl
Portugal	Dr Anabela Isidro	Fundação para a Ciência e Tecnologia (FCT) Departamento das Relações Internacionais Anabela.Isidro@fct.pt +351 21 391 15 52
Romania	Mihaela Manole	Executive Agency for Higher Education, Research, Development and Innovation Funding (UEFISCDI) Mihaela.manole@uefiscdi.ro +4 021 30 23 863
Slovakia	Katarina Bibova	Slovak Academy of Sciences (SAS) bibova@up.upsav.sk +421 2 5751 0136 www.sav.sk
Spain	Clara Martín	National Institute of Health Carlos III (ISCIII) SG de Programas Internacionales de Investigación y Relaciones Institucionales +34 91 822 25 67 c.martin@isciii.es
Spain	Ana Barra	State Research Agency (AEI) neuron@aei.gob.es +34 91 603 83 98
Switzerland	Dr Carolin von Schoultz	Swiss National Science Foundation (SNSF)Division Biology and Medicine carolin.vonschoultz@snf.ch +41 31 308 23 25
Taiwan	Dr Ching-Mei Tang	National Science and Technology Council (NSC) https://www.nstc.gov.tw/ Tel: +886-2-2737-7557 cmtom@nstc.gov.tw
Turkey	Dr Recep Emrah Çevik	The Scientific and Technological Research Council of Turkey (TÜBİTAK) www.tubitak.gov.tr emrah.cevik@tubitak.gov.tr

Annex II. Anticipated amount of funding provided by each partner

The intended contribution by each participating funding organisation to be used for the joint transnational call for research projects is listed below.

Partner Country	Funding organisation	Anticipated amount of funding (for 3 years)	Anticipated number of fundable research groups
Belgium	Fonds de la Recherche Scientifique-FNRS (F.R.S.-FNRS)	200.000€	1
Belgium	Research Foundation – Flanders (FWO)	700.000€	2-3
Croatia	Ministarstvo Znanosti i Obrazovanja (MZO)	200.000€	1
Estonia	Estonian Research Council (ETAg)	100.000€	1
Finland	Suomen Akatemia (AKA)	600.000€	2
France	French National Research Agency (ANR)	2. 700. 000€	~9-10
Germany	Federal Ministry of Education and Research (BMBF)	3.000.000€	10
Hungary	National Research, Development and Innovation Office (NKFI)	300.000€	2
Ireland	Health Research Board (HRB)	370.000€	1-2
Israel	Ministry of Health (CSO-MOH)	300.000€	2
Italy	Ministry of Health (MOH)	1.500.000€	6
Latvia	State Education Development Agency (VIAA)	360.000€	2
Norway	The Research Council of Norway (RCN)	1000.000€	3-5
Poland	National Centre for Research and Development (NCBR)	600.000€	1-3
Portugal	Foundation for Science and Technology (FCT)	250.000€	1-2
Romania	Executive Agency for Higher Education, Research, Development & Innovation Funding (UEFISCDI)	500.000€	1-2
Slovakia	Slovak Academy of Sciences (SAS)	240.000€	2
Spain	National Institute of Health Carlos III (ISCIII)	500.000€	2-3
Spain	Spanish State Research Agency (AEI)	1000.000€	6
Switzerland	Swiss National Science Foundation (SNSF)	~1.100.000€ (CHF 1.200.000)	3-4
Taiwan	Ministry of Science and Technology (MOST)	810.000€	2-3
Turkey	The Scientific and Technological Research Council of Turkey (TUBITAK)	300.000€	2-3

Annex III. Call Timetable

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^[1]Excerpt of definition from ICD11, please note that schizophrenia and bipolar disorders are not excluded in this call.

^[2]Eligibility and funding requirements for clinical trials vary between the partner countries. Clarification may be obtained from the individual funding organisations.

^[3]Alzheimer’s disease and other neurodegenerative dementias, Parkinson’s disease (PD) and PD-related disorders, Prion disease, Motor neuron diseases, Huntington’s disease, Spinocerebellar ataxia, Spinal muscular atrophy

^[4]Please check carefully the national regulations for further information on eligible beneficiaries

^[5]For Romanian institutions recommended for funding, projects must start at the end of 2021.

^[6] Last name, first name of the researchers, date of birth, professional contact information, degree(s), position (current and previous), fields of activity, place of work, organisation, address(es), curriculum vitae, ORCID number, name and reference of projects, pre-proposals, project proposals (scientific document, administrative and financial appendix).

^[7] Countries partaking in ERA-NET NEURON outside the European Economic Area: Canada, Israel, Switzerland, Taiwan, and Turkey.

^[8]UK: pending Brexit process

^[9]For Romanian institutions recommended for funding, projects must start at the end of 2021.