ERA4Health Partnership 2025 “EffecTrial”

A brief summary of the call is provided below along with additional information on eligibility for applicants requesting funding from HRB. Please refer to ERA4Health EffecTrial website for all call documents:

Beyond the research topics, the following requirements and recommendations should be considered, ncluding approaches to Responsible Research and Innovation (RRI) (see RRI guidelines provided in the Guidelines for Applicants document on the ERA4Health EffecTrial website).

Requirements:

• Proposals must clearly demonstrate the potential health and/or economic impact(s) as well as the added value of transnational clinical collaboration.
• Proposals must include an early involvement of ‘end users’ (e.g. patients, care providers, healthcare professionals, etc.) in the design of the study (integrating patient valued outcomes) and in the research process. This is to ensure acceptability of the healthcare intervention and utility of the studies’ knowledge for healthcare decision making. Patient organisations or other end-users can participate as partners (if eligible for funding by a national/regional funding organisation), as collaborators (participation with own budget) or as part of an advisory board.
• Special consideration must be given to fulfilling all ethical requirements (See ethical requirements and clearance section in the call documents, including reference to Reference to EU Regulation 2021/695 and ethical self-assessment).
• The consortia shall ensure the management of research data according to FAIR data principles (Findability, Accessibility, Interoperability and Reuse) and in compliance with the General Data Protection Regulation (GDPR).
• The proposed research shall consider sex and gender aspects, whenever applicable.
• Partners in the consortia, especially the coordinating PI, should have a proven track record in delivery of clinical trials to ensure the feasibility of the clinical trial.
• The consortia should consider the gender balance in their composition and to balance the responsibilities between them.
• Additionally, proposals should take into account the diversity of health systems in different regions of Europe to allow large-scale uptake.
• The consortia are requested to ensure inclusiveness aspects in patient recruitment (minorities, ethnical aspects), to include underrepresented and vulnerable populations that could be specifically relevant in a certain medical area and consider issues of particular relevance for the target population, for example, gender specificities, age, multimorbidity, complex chronic conditions, polypharmacy, substance misuse, vaccine efficacy, compliance, and diseases with high societal burden.
• For the chosen population, clinical and safety parameters, as well as health and socioeconomic outcomes (e.g. quality of life, patient mortality, (co)morbidity, costs, and performance of the health system) should be assessed. 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.

Out of Scope:

• Studies in other medical areas different from the ones abovementioned (cardiovascular diseases, metabolic disorders, nutrition and lifestyle-related diseases and non-communicable respiratory diseases).
• Particularly, those clinical trials that are focused on rare diseases, cancer and/or infectious diseases are out of the scope of this call, even if these diseases are studied with one of the eligible diseases/conditions.
• Proposals focused on observational studies, cohort studies, translational / clinical approval studies, creation of large databases, systematic reviews and meta-analysis.
• Basic biomedical research.
• Development of a new healthcare intervention.
• Phase I and phase II studies.
• Placebo randomized controlled trials.

Recommendations:

• Additionally, proposals are encouraged to show how the outcomes of the trial could generate further impact in the future (e.g. through a socioeconomic evaluation and to demonstrate how the evidence shown by the comparative-effectiveness clinical trial could be very valuable for future Health Technology Assessments (HTA).
• The consortia are encouraged to take into consideration existing multinational networks, platforms or existing cohorts in the respective medical field that they have access to ensure the feasibility of the trial.
• Applicants could make use of existing biobanks, existing cohorts, information from previous observational studies, systematic reviews, and/or metadata repositories, although their clinical studies should not be based only on this type of approaches.

Irish Partner(s) are not eligible for HRB funding for:

• Applications from individuals applying for, holding, or employed under funding received from the tobacco industry.[1]
• Applications from individuals applying for, holding, or employed under funding received from the alcohol industry and related actors.[2]

[1] Any company, entity, or organisation involved in the development, production, promotion, marketing, or sale of tobacco in any country of the world. The term also includes any companies that are a subsidiary or a holding company or affiliate of the above. This also includes e-cigarette companies and non-tobacco related companies which are fully or partially owned by the tobacco industry

[2] Including social aspects/public relations organisations (SAPROs) funded by alcohol companies or trade associations in which such companies are members.

Projects are expected to start between January and May 2026. Awards will have a duration of 48 months.

For applicants based in Ireland, the HRB will provide funding for projects up to a maximum of €1,000,000 including overhead contribution.

The HRB plans to commit up to €1,200,000 to the ERA4Health EffecTrial awards. Quality permitting a minimum of one award will be funded.

The award will offer research related costs for:

• Personnel: Salary-related costs in line with the most recent IUA (or other most applicable) scale for funded personnel.
• Direct running costs (including travel, mobility costs, patient-related costs)
• PPI costs
• Small equipment costs (not to exceed €10k)
• FAIR data management costs: Data stewardship costs (e.g. service/fees from data steward, access to secondary data, costs of making data FAIR, etc). Please refer to Appendix I for additional guidance on FAIR data management costings.
• Open access costs
• Dissemination and knowledge exchange activities (including dissemination-related travel)
• Overheads contribution

Funding available is inclusive of overheads and pension contributions.

Note: The ERA4Health JTC EffectTrial award will not fund PhD stipends and fees, nor the salary and related costs of tenured academic staff within research institutions (including buy-out from teaching time etc).

The budget requested and the award duration must reflect the scale and nature of the proposed research.

Funded Personnel

Alignment between personnel requested and the proposed project should be demonstrated. Roles and responsibilities of funded personnel must be differentiated and clear.

This scheme is not framed as a training initiative for higher degree candidates. It will not cover costs for PhD students

This call is not open for Host Institutions in Northern Ireland.

Only transnational projects will be funded and consortia must meet specific criteria as detailed in the call text. There will be a partner search tool available for this call. Please refer to the ERA4Health EffecTrial website for all details.

Lead Applicants requesting HRB funding:

Note that HRB use the term ‘Lead Applicant’ to refer to a coordinator or partner applying for HRB funding.

The HRB will only contract with the Host Institution of the Lead Applicant. The Lead Applicant will serve as the primary point of contact for the HRB during the review process and on the award, if successful. They will be responsible for the scientific and technical direction of the Irish research programme. They have primary fiduciary responsibility and accountability for carrying out the research within the funding limits awarded and in accordance with the terms and conditions of the HRB. Where applicable, they must distribute the funds appropriately to associated partner(s) based in Ireland via collaboration and/or consortium agreements.

Lead Applicants must:

Hold a post (permanent or a contract that covers the duration of the award) in a HRB recognised Host Institution in the Republic of Ireland (the “Host Institution”) as an independent investigator. For clinicians, an adjunct position in a HRB recognised Host Institution is acceptable (an accompanying letter of support is required in these cases, as well as in the case of contract positions – see Section 6 below).

OR

Be an individual who will be recognised by the Host Institution upon receipt of an award as an independent investigator who will have a dedicated office and research space for the duration of award, for which they will be fully responsible. The Lead Applicant does not necessarily need to be employed by the Host Institution at the time of the application submission (an accompanying letter of support is required in these cases – see Section 6 below).

They must show evidence of achievement as an independent researcher in their chosen research field by:

• Demonstrating a record of research output, with at least three publications of original research in peer reviewed journals. Where appropriate, they should also provide evidence of other outputs (e.g., published book chapters, reports to government, research data and datasets, research materials, databases, audio/video products, national and/or international reports, patents, models and protocols, software production, evidence of influence on health policy and practice, outreach and/or knowledge exchange activities, media coverage or other relevant activities) and/or any other relevant outputs that have resulted in a significant impact in their field.
• Demonstrating record of independence by showing that they have secured at least one peer-reviewed research grant for a research project/s, as either the Lead Applicant or a Co-Applicant. Funding received for travel to seminars/conferences and/or small personal bursaries will not be considered in this regard.
• Show evidence that they possess the capability and authority to manage and supervise the research team.

Host Institution:

The Host Institution for the award is normally that of the Lead Applicant based in Ireland. In order to be eligible to apply for funding, an Institution must be an approved HRB Host Institution no later than two calendar months before the closing date of a call. A list of currently approved HRB Host Institutions can be found on the HRB website.

HRB will contract with a single Host Institution (Lead Applicant). Additional national recruiting sites (associate partners) are permitted to join the consortium. The Lead Applicant will be responsible for appropriate distribution of funds to the associated partner(s) via collaboration and/or consortium agreements.

The HRB does not have a limit on the number of associated partners that will act as clinical study sites.

There will be a 2-stage application procedure for joint applications. One joint proposal document (in English) shall be prepared by the partners and must be submitted by the Coordinator in electronic format no later than 15:00 GMT on 28 January 2025 via the electronic proposal submission system (link will be available on the ERA4Health EffecTrial website). No other means of submission will be accepted.

For further details, please refer to the respective submission forms available through the ERA4Health EffecTrial website. If you need additional information, please contact the Joint Call Secretariat (JCS). Please refer also to HRB Grant Policies.]

Lead Applicants based in Ireland will be required to provide additional information to the HRB:

• Applicants must demonstrate that they meet the eligibility criteria by completing the Lead Applicant eligibility form by the submission deadline (only applies to new applicants to Joint Transnational Calls).
• Host Institution Letters of Support must be provided for Adjunct Professors not directly employed by the HI. These must be emailed to EUTrials@hrb.ie or attached with your Lead Applicant eligibility form before the pre-proposal submission deadline. The formal letter on headed notepaper, dated and signed by the Head of School/Research Centre/Hospital must include the following information: [Host Institution – insert name] confirms that [applicant – insert name] has the authority and resources allocated to hold and manage a grant under their Adjunct status for at least the duration of the award.
• At full proposal stage, applicants must submit a justification for their requested budget, and clarification on deliverables assigned to the partner from Ireland. Templates requesting this information will be provided by the HRB.

For general information, please contact the Joint Call Secretariat (JCS):

Astrid Valencia Quiñónez and Sara García-Rodríguez

Email: EffecTrial@isciii.es

For country-specific information for Irish Partners, please contact the HRB, Ireland:

Karen Crowley

Email: EUTrials@hrb.ie