Research infrastructure services to enable R&I addressing main challenges and EU priorities related to the health domain

For all areas:

• Provision of innovative, customised and efficient research infrastructures services enhancing and increasing society’s long-term and consistent problem-solving capacity and evidence-based policy making related to the health domain.

Project results are expected to contribute to all of the following expected outcomes for one of the areas:

Area 1: research infrastructure services to support research and development of medical countermeasures for epidemic response:

• Excellent research and innovation to identify, characterise and mitigate the effects of existing and future emerging pathogens of public health concern.
• Comprehensive catalogue of research infrastructure services relevant to tackle infectious diseases epidemics, updated and available.
• Increased knowledge on, and development of intervention tools against (re)emerging pathogens enabled by relevant research infrastructure services.
• Availability of research data emerging from access provision activities for re-use on common data platforms and registries, according to FAIR principles and compliant with legal provisions under the General Data Protection Regulation (GDPR).
• Challenge driven integration of EU research infrastructures and organisational and structural alignment with the future Pandemic Preparedness Partnership, the EU Reference Laboratories and the EU4Health funded laboratory network DURABLE (or relevant legacy initiative).
• Providing a long-term sustainability concept for such a research infrastructure network supporting epidemic research.

Area 2: research infrastructure services for improving clinical research in the paediatric area:

• Advancement of paediatric medicines and other therapeutic and diagnostic approaches for this population group to markets and towards clinical use;
• Accelerated availability of solutions and products to paediatric patients in need;
• Wider access to rationally designed research infrastructure services across Europe to underpin the competitiveness of the European industry and of biotech SMEs developing paediatric medicines and treatment and diagnostic devices;
• Joined forces of research infrastructures and paediatric competence networks in EU Member States and Associated Countries, to facilitate paediatric research in the context of pertinent EU regulatory environment;
• Availability of innovative tools to conduct paediatric clinical trials, for the re-use of population and historical data, and for enhanced data sharing across actors at different care levels and across regions in Europe.

Area 3: research infrastructure services to enable research linking environmental factors to human health:

• Better risk assessment tools and data evidence to anticipate and mitigate negative environmental implications on human health;
• Evidence to inform policy making and public health bodies with respect to assessment and management of environmental risks for human health;
• Wider access to specialised research infrastructure services to underpin the competitiveness of the European industry including SMEs active in the field of risk assessment and management of environmental impact on human health.
• Link with the environmental research on the exposure to other living organisms within the One-Health concept.

This topic aims at providing trans-national access (on-site or remote) and/or virtual access to integrated and customised research infrastructures services for challenge-driven research and innovation in each of the areas listed below, all related to the health domain, offered by a wide range of complementary and interdisciplinary top level research infrastructures.

Access also includes ad hoc users’ training and scientific and technical support. Training courses for using the infrastructures may also be supported. Training courses and ad hoc users’ training will prepare the new generations of researchers to properly exploit leading-edge research infrastructures, and should provide them with appropriate skills for data stewardship.

Activities to facilitate and integrate the access procedures, to further develop the remote or virtual provision of services and to improve, customise and harmonise the services the infrastructures will also be supported, including for better serving the needs of open EU industrial research and innovation.

The main goal of this topic is access provision to existing services: this should be clearly reflected by the proposed activities and the allocated resources. The improvement and optimisation of the offered services and the development of new services, relevant to the challenges, will also be supported, including joint/cross- research infrastructures services provided the resulting services are opened and offered already under the actions (short term R&D) and that the long-term sustainability of such services is ensured by the participant research infrastructures. Further development of new or improved services for use in the mid-term (2-3 years) may also be supported when duly justified e.g. to address well-identified needs such as in the ESFRI Landscape Analysis, or in the research agendas of Horizon Europe Pillar II Missions or European Partnerships. The topic will not support longer-term R&D for new instrumentation, tools, methods and advanced digital solutions.

Proposals should adhere to the guidelines and principles of the European Charter for Access to Research Infrastructures^[1]

Data management (and related ethics issues), interoperability, as well as the connection of digital services (e.g. data services) to the European Open Science Cloud, should be addressed where relevant.

Proposals should take due account of major European or international initiatives relevant in the domain. When appropriate, they should foster the use and deployment of (open) global standards.

Proposals should make available to researchers a wide, inclusive and comprehensive portfolio of complementary research infrastructure services, including data services, and customised workflows to enable R&I addressing the set challenge. To this extent, they should involve - as beneficiaries, affiliated entities, third parties, or external providers of purchased services - the necessary interdisciplinary set of research infrastructures of European interest^[2] that provide such services.

Proposed actions should ensure that they are strongly linked to research infrastructures of pan-European relevance, as prioritised by ESFRI and the ERICs. Therefore, proposals should include at least one ESFRI Landmark^[3] or European Research Infrastructure Consortium (ERIC)^[4] as beneficiary. In case of a distributed^[5] ERIC, as an alternative to the ERIC participating as a beneficiary, a legal entity that is hosting ERIC facilities, resources or related services may participate as a beneficiary. A declaration signed by the legal representative of the ERIC should confirm that the ERIC is supporting this participation, explain the relevance for the ERIC and describe any further cooperation with the ERIC.

Access could also be open, in accordance with the ‘Specific Features for Research Infrastructure’ section of this Work Programme, to third countries’ researchers to work on global challenges. Research infrastructures from third countries^[6] may be involved when appropriate. However, such research infrastructures should only be involved, as beneficiaries or affiliated entities, if they offer complementary or more advanced services than those available in EU Member States and Associated Countries.

Proposals should include an outreach and engagement plan to actively advertise their services to targeted research communities, notably from Widening countries and, if applicable, to relevant industries, including SMEs.

Proposals are expected to exploit synergies and to ensure complementarity and coherence with other EU grants supporting access provision.

Proposals should include the list of services/installations^[7] opened by research infrastructures for trans-national or virtual access and the amounts of units of access made available for users. Further conditions and requirements relating to access provisions that applicants should fulfil when drafting a proposal are given in the “Specific features for Research Infrastructures” section of this work programme part. Compliance with these provisions will be taken into account during evaluation.

In this topic the integration of the gender dimension (sex and gender analysis) in research and innovation content is not a mandatory requirement. However, where applicable, proposals should promote in their calls for access the integration of the gender dimension in the research and innovation content of the users applying to these calls.

The topic targets the following scientific challenges and EU priority areas related to the health domain. Proposals are expected to address one of the following areas and must explicitly state which area they address:

Area 1: Research infrastructure services to support research and development of medical countermeasures for epidemic response

The proposals in this area should build on the integrated research infrastructure services comprehensive and inclusive portfolio to support epidemic preparedness research, provide the capacity to respond to infectious disease epidemics, and underpin leading research in the domain. It should build on work already carried out following the HORIZON-INFRA-2021-EMERGENCY-02 call and the ISIDORe project.

The proposed action should support the provision of trans-national and/or virtual access to researchers, training for using the infrastructures, activities to improve and customise the services the infrastructures provide, as well as facilitating and integrating access procedures, and further developing the remote or virtual provision of services. Proposals should foster increased access to national research infrastructures through outreach activities targeting relevant user communities.

Access to research infrastructure services should be provided to users to support their research projects targeting: i) basic research meant to increase knowledge on pathogens with epidemic potential, and/or ii) the development of new or adapted prevention and/or intervention tools and measures. These include new or adapted diagnostic procedures and therapies, drugs, vaccines, or disease vector control.

Reflecting the One-Health concept, services supporting research on transmission of pathogens from animals to humans (or vice versa, animals as host reservoir), including vector-borne transmission, should be covered. Flexibility in the provision of services should be properly demonstrated to ensure fast re-orientation and expansion of the portfolio in response to unexpected epidemics situations. Effective operational links established within the ISIDORe project with the epidemics risk assessment and management bodies like ECDC, WHO, WOAH, and EU-HERA should be ensured. Furthermore, alignment with the future Pandemic Preparedness partnership should be taken into consideration. Global standards, relevant data platforms and registries should be used to make user project results FAIR and usable, thus enabling further research on pathogens and disease manifestation.

Proposals could consider the inclusion of the European Commission's Joint Research Centre (JRC) research infrastructure (Nanobiotechnology laboratory) in their research infrastructure portfolio for biophysical characterisation of recombinant proteins, antigens, therapeutic antibodies, lipid nanoparticles therapeutic and its expertise at the interface between the research activities and regulatory aspects. In that respect, the JRC will consider collaborating with any successful proposal and this collaboration, when relevant, should be established after the proposal’s approval.

Area 2: Research infrastructure services for improving clinical research in the paediatric area

Paediatric healthcare in EU and worldwide is often hampered by an enduring lack of specific medicines and therapies tailored for use in paediatric population. Proposals should integrate and give access to research infrastructure services to enable and accelerate R&I towards innovative biomedical products and therapies for children, including new-borns. They should support in particular, but not limited to, clinical R&I projects addressing therapeutic, diagnostic and prevention measures for paediatric disease management and help these projects to meet regulatory requirements for licensure and clinical use of paediatric medicines and medical devices.

Due to the peculiarities of paediatric clinical research with study subjects often dispersed across Europe, research infrastructure services offered should include innovative trial designs and novel monitoring tools, including the necessary support at local level. GDPR compliant and regulatory acceptable access and re-use of relevant population, historical and real world care data should be facilitated, as should be the harmonisation of respective ethics reviews across Europe.

As paediatric research is often faced with locally dispersed case incidences, wider geographical outreach and international collaboration beyond Europe, including with LMIC (Low-to-Middle-Income Country) is strongly encouraged.

Appropriate links and alignment should be ensured with EU level initiatives such as EnprEMA, and Horizon Europe partnerships such as the Innovative Health Initiative, the Transforming Health and Care Systems partnership, the Personalised Medicine partnership (EP PerMed), the ERA for Health Research (ERA4Health), and the partnership on Rare Diseases research (ERDERA).

Data management should duly cater for interoperability of data services, while contributing to GDPR compliant access modalities as required in the European Health Data Space. Metadata, statistical and anonymised data sets should duly comply with FAIR principles to become accessible under the European Open Science Cloud.

Area 3: Research infrastructure services to enable research linking environmental factors to human health

Human health is strongly dependant on exposure to environmental factors^[8] with 10% of all premature deaths in EU linked to environmental pollution.^[9].. Proposals should integrate and give access to a wide range of monitoring and experimental research infrastructure services to investigate the effect of environmental exposure. Services should be provided to user projects aiming to characterize environmental risk factors (e.g. of chronic health conditions) and/or to develop innovative tools and methods for deciphering the causal pathways and the prevention of associated diseases. Integration of multiple types of data reaching from environmental exposure measurements to granular human omics, analytical and clinical data including also socio-economic and lifestyle data, in line with One-Health approach, is key for this type of research at the interface of environmental and health research.

Proposals in this area should customise and further develop research infrastructure services to meet the needs of ongoing research in the field. Appropriate links and complementarities should be ensured with relevant ongoing initiatives and resources, such as pertinent ESFRI roadmap efforts, e.g. EIRENE^[10], the European Human Exposome Network (EHEN), the Information Platform for Chemical Monitoring (IPCHEM), the EC Knowledge Centre on Cancer^[11], the European Microwave Signature Laboratory, the European Partnership for the Assessment of Risks from Chemicals (PARC), and other Horizon Europe relevant projects including the ones emerging from the 2023 and 2024 ‘Environment and health’ calls of Cluster 1 - Health.

Proposals could consider the inclusion of the European Commission's Joint Research Centre (JRC) research infrastructure (Water Laboratory) in their research infrastructure portfolio for wastewater surveillance for various application fields from One-Health use cases, biosecurity and water resilience including water reuse and irrigation, as well as its expertise at the interface between the research activities and regulatory aspects. Proposals could also consider the inclusion of the JRC’s High Throughput Testing (HTT) facility, which automates in vitro toxicology methods to generate large datasets from bespoke chemical libraries. Such data can be used in a variety of ways to explore potential links between exposure to environmental chemicals and their mixtures and adverse effects on human health. The JRC will consider collaborating with any successful proposal.

[1] https://op.europa.eu/publication-detail/-/publication/ec4692ae-ac6f-11ef-acb1-01aa75ed71a1

[2] A research infrastructure is of European interest when is able to attract users from EU or associated countries other than the country where the infrastructure is located. This includes ESFRI and ERIC infrastructures.

[3] See lists of ESFRI 'Landmarks‘ in the 2021 ESFRI Roadmap on https://roadmap2021.esfri.eu/

[4] European Research Infrastructure Consortium (ERIC) | European Commission (europa.eu)

[5] The term ‘distributed’ research infrastructure typically refers to one or a few central hubs and several interlinked (national or institutional) nodes where many components of the research infrastructure may not be part of the same legal entity, the ERIC.

[6] See the Eligibility conditions for this topic.

[7] “Installation” means a part or a service of a research infrastructure that can be used independently from the rest. A research infrastructure consists of one or more installations.

[8] Physical substance (solids, liquids or gas) or energy (e.g. noise, light, electromagnetic fields, radioactive radiation, etc.) present in the environment.

[9] EEA: https://www.eea.europa.eu/en/topics/at-a-glance/health

[10] EIRENE RI, Research Infrastructure for EnvIRonmental Exposure assessmeNt in Europe

[11] The knowledge centre on Cancer and its five pillars: 1) Health Promotion and Disease Prevention Knowledge Gateway 2) The European Cancer Information System (ECIS) and the European Network of Cancer Registries (ENCR) 3) The European Commission Initiatives on Breast and Colorectal Cancers 4) The Cancer Inequalities Registry, 5) The European Platform on Rare Disease Registration (EU RD Platform)