Horizon Europe (HORIZON-HLTH-2024-DISEASE-03-08-two-stage)

Eligibility

1. Admissibility conditions: described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes. Applicants submitting a proposal under the blind evaluation pilot (see General Annex F) must not disclose their organisation names, acronyms, logos, nor names of personnel in Part B of their first stage application (see General Annex E). Proposal page limits and layout: described in Part B of the Application Form available in the Submission System.

2. Eligible countries: described in Annex B of the Work Programme General Annexes.

Canadian-based researchers may be co-applicants but are not automatically eligible for funding and therefore by default have to participate at their own cost. These participants should explain in the proposal how their funding will be secured. They may, however, receive exceptional funding, if the granting authority considers that their participation as a beneficiary is essential for implementing the project, for example in view of their: 

• outstanding competence/expertise 
• access to particular research infrastructures 
• access to particular geographical environments 
• access to particular data.

Summary

Program Topic: Tackling diseases and reducing disease burden

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to most of the following expected outcomes:

• Health policymakers are aware of the healthcare interventions (pharmacological, non-pharmacological or technological interventions; including preventive and rehabilitative actions) that are identified as working best for the specific population groups from the point of view of safety, efficacy, patient outcomes, adherence, quality of life, accessibility, and (cost-) effectiveness.
• Health professionals have access to and use the improved clinical guidelines on the optimal treatment of patients and prevention of diseases e.g. through vaccines. Considerations made in the guidelines include the harmonisation and standardisation of care for high burden diseases or conditions throughout Europe, as well as possible individualised needs of patients.
• The scientific and clinical communities make effective use of state-of-the-art information, data, technologies, tools and best practices to develop interventions that are sustainable.
• Citizens, patients, prescribers, and payers receive more accurate information on available healthcare interventions via ad hoc communication platforms.
• The scientific and clinical communities make wide use of the newly established open access databases and/or integrate them with existing open access infrastructures for storage and sharing of collected data according to FAIR principles.

Scope: Effective, affordable and accessible healthcare for diverse population groups is challenging and complex. For example, specific needs underlie the delivery of effective preventive actions and therapeutic treatments to a rapidly growing elderly population, often presenting comorbidities and associated polypharmacy. The paediatric population, including children born preterm, has also its specific needs in specially adjusted therapeutics and early interventions to address emerging health and developmental problems. Similar to the elderly population, the paediatric population is often excluded from many clinical trials that generate the evidence base for healthcare interventions. Women, including pregnant women, are also often under-represented in clinical studies and access to quality healthcare is frequently inadequate. Other population groups with limited access to quality healthcare and/or under-representation in clinical studies include low-income groups, and refugees. Intersectionality within these groups also needs consideration.

Proposals should address most of the following:

• Compare the use of currently existing (pharmacological, non-pharmacological and technological) healthcare interventions in specific population groups (or selected subgroups). While there is no restriction on diseases or conditions, preference will be given to proposals focusing on interventions with high public health relevance.
• Ensure acceptability and sustainability of the healthcare intervention through early involvement of ‘end users’ (e.g. patients, care providers) in the design of the study (integrating patient valued outcomes) and, where possible, in the research process including implementation. Additionally, proposals should take into account the diversity of health systems in different regions of Europe to allow large-scale uptake.
• Consider involving HTA bodies in order to create synergies and accelerate the practical implementation of the results. Where relevant, existing work of EU-funded projects such as EUnetHTA should be also taken into account.
• Consider issues of particular relevance for the target populations, for example, multimorbidity, complex chronic conditions, polypharmacy, substance misuse, vaccine efficacy, compliance, age, gender specificities and diseases with high societal burden (including but not limited to e.g. musculoskeletal diseases and mental health disorders). Special consideration should be given to fulfilling all ethical requirements.
• For the chosen population, assess clinical and safety parameters, as well as health and socio-economic outcomes (e.g. quality of life, patient mortality, (co)morbidity, costs, and performance of the health system). Agreed core outcome sets (COS) should be used as endpoints in conditions where they already exist, in other cases, efforts should be made to agree on such COS. Consider using new instruments and methods for determining the burden of disease and for evaluating the effects of the interventions. Low-cost innovations should also be considered.
• Inclusion of patient organisations and associations of caregivers and other healthcare professionals is recommended.
• Clinical trials, including pragmatic clinical trials, observational studies, use of existing health data in different study designs, creation of large-scale databases and performing meta-analyses may be considered for this topic. Use of existing data should always be considered to add value, increase quality and increase implementation speed of the study. Regarding databases, sustainability after the proposed action's end also needs to be considered.
• The proposed research needs to take into account sex and gender aspects.

This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.

The Commission will ensure an overall coordination mechanism between the projects funded under this topic to catalyse the exchange of knowledge, as well as the development and adoption of best practices. Proposals are expected to budget for the attendance to regular meetings. Projects resulting from this call will be invited to share and discuss their case studies amongst themselves and with relevant stakeholders at the EU level, and necessary resources should be allocated to this task.

Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

Two-Stage Submission Process:

• stage 1 — applicants submit a short outline proposal, which is evaluated. University of Calgary participants should submit an RMS pre-award/Letter of Intent record for review and approval by September 14, 2023 - 12:00 PM MT.
• stage 2 — for successful proposals, applicants are invited to submit a full proposal, which will again be evaluated. University of Calgary participants should inform the RSO of their invitation to submit a full proposal, and an RMS pre-award/application record will be generated from their LOI record. RMS pre-award applications should be submitted for review and approval by April 8, 2024 - 12:00 PM MT.

Overhead

Variable

Pre-application deadlines

RSO internal deadline

Pre-application program deadline

Application deadlines

RSO final internal review deadline

Program application deadline

NOTE: Consult your Faculty Associate Dean (Research) (ADR) regarding Faculty-specific deadlines and submission processes.

Principal Investigators: Complete a Research Management System (RMS) record, including a copy of your complete application, and submit this for approvals in RMS.

Approvals: The University of Calgary requires that all funding applications be approved prior to submission. Approval requires signatures in the following order:

• Principal Investigator
• Department Head
• Faculty ADR/Dean
• Research Services (on behalf of the Vice-President Research)

Read the Meaning of Grant Signatures policy to understand what your approval means. Please see the agency guidelines for details about which signatures are required on your application, as it may differ from internal requirements.

Late submissions: Late submissions will only be accepted in cases of medical or family emergencies, or other exceptional circumstances. If you submit your RMS record to Research Services after the internal deadline has passed, you must secure additional approvals. Please read: Late Applications Process.

Call documents:

Standard application form (HE RIA IA Stage 1) - call-specific application form is available in the Submission System
Standard application form (HE RIA, IA) - call-specific application form is available in the Submission System
Standard evaluation form (HE RIA, IA and CSA Stage 1)
Standard evaluation form (HE RIA, IA)

Lump Sum MGA v1.0

Information on clinical studies (HE)
Guidance: "Lump sums - what do I need to know?"
Detailed budget table (HE LS)

Additional Documents

HE Main Work Programme 2023–2024 – 1. General Introduction
HE Main Work Programme 2023–2024 – 4. Health
HE Main Work Programme 2023–2024 – 13. General Annexes

HE Programme Guide
HE Framework Programme and Rules for Participation Regulation 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Funding & Tenders Portal Terms and Conditions
Funding & Tenders Portal Privacy Statement