European Rare Diseases Research Alliance 2025

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

Topics list:

Research studies on therapies using small molecules, small non-coding chemically synthesized nucleic acid-based therapies, repurposed drugs or biologicals (e.g., antibodies or proteins such as enzymes, immune modulators or growth factors etc.). Proposals must cover at least two of the following areas:

• Development of novel therapies in a pre-clinical setting through cell, organoid and animal disease model studies, and/or use of in silico or artificial intelligence models to accelerate the success rate of the pre-clinical stage
• Development of predictive and pharmacodynamics biomarkers correlated to the efficiency of the therapy in a preclinical setting that could serve as surrogate endpoints
• Replication of pre-clinical studies in an independent lab to increase validity of exploratory findings
• Pre-clinical proof of concept studies for evidence of pharmacological activity in vitro and in vivo, pharmaco-kinetics and pharmaco-dynamics of the investigational drug (i.e., small molecule(s) and/or biologic) and first toxicology and safety data as well as studies to support readiness for initiating clinical trial authorization conforming to regulatory requirements

Translatability into humans should be the key focus of the project, and applicants should demonstrate access to relevant scientific or regulatory expertise (e.g., through innovation task forces or competent national authorities).

Excluded Approaches and Topics:

• ATMP therapies (gene therapy medicinal product (including mRNA-based therapies), somatic cell therapy medicinal product, tissue engineered product, according to EMA definition).
• Development of new cell/organoid/animal models, which should already be established.
• Set-up or extension of natural history studies/patient registries.
• Interventional clinical trials to prove efficacy of drugs/treatments/surgical procedures/medical procedures. This includes studies comparing efficacy, e.g., two surgical techniques or therapies, and projects whose main objective is the implementation of a clinical phase IV pharmacovigilance study.
• Projects focusing only on rare neurodegenerative diseases that are within the focus of the Joint Programming Initiative on Neurodegenerative Disease Research (JPND). These are: Alzheimer’s disease and other dementias; Parkinson’s disease (PD) and PD-related disorders; Prion diseases; Motor Neuron Diseases; Huntington’s disease; Spinal Muscular Atrophy and dominant forms of Spinocerebellar Ataxia. Interested researchers should refer to the relevant JPND calls (see HRB’s JPND JTC2025 pre-announcement). However, childhood dementias/neurodegenerative diseases are eligible.
• Rare infectious diseases, rare cancers and rare adverse drug events in treatments of common diseases. Rare diseases with a predisposition to cancer are eligible.

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

• Proposals involving basic biomedical research;[1]
• Research intended to create human embryos solely for the purposes of research or for the purposes of stem cell procurement, including by means of somatic cell nuclear transfer;
• Applications from individuals applying for, holding, or employed under funding received from the tobacco industry;[2]
• Applications from individuals applying for, holding, or employed under funding received from the alcohol industry and related actors.[3]

[1] Basic biomedical research refers to very early stage, fundamental research. HRB permits pre-clinical research within this call on the understanding that pre-clinical studies represent an important stage of research that occurs before testing in humans to find out if a drug, treatment or procedure is likely to be useful. Work with animal models and human samples is eligible under this call.

[2] 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

[3] 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 in 2026. Awards will have a duration of up to 36 months.

Please note: Project partners will be funded by their relevant national/regional funding organisations. Eligible costs and funding rules may vary between the respective funding organisations (see the call text).

For applicants based in Ireland, the HRB will provide funding for projects up to a maximum of €330,000 direct costs per award. Additional funding of up to €75,000 direct costs will be made available for coordination activities (cannot be used to cover equipment and consumables) bringing the total to €405,000 direct costs for coordinators. The maximum total award, including overhead contribution, will be €430,000, for a partner and €530,000 for applicants who take on the role of coordinator.

The HRB plans to commit up to €530,000 to the ERDERA JTC2025 awards. Quality permitting a minimum of one award will be funded.

The award will offer research related costs for:

• Personnel: (i) Salary-related costs in line with the most recent IUA (or other most applicable) scale for funded personnel; (ii) Salary related costs for Lead Applicants in contract positions up to a maximum of 0.5 FTE protected time for research funded by HRB; (iii) Postgraduate stipends and fees (Master’s students only).
• Direct running costs (including travel, mobility costs, patient-related costs, and costs to support interventional studies)
• PPI costs
• Small equipment costs (not to exceed €10k)
• 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.
• Dissemination and knowledge exchange activities (including dissemination-related travel)
• Sub-contracting costs for the provision of a service can be covered up to a maximum of 20% of direct costs. This would need to conform with the Host Institution, National and EU procurement rules. These costs should be necessary, specific to the project and proportionate and they should normally constitute only a limited part of the project.
• Overheads contribution

Funding available is inclusive of overheads and pension contributions.

Please refer to “HRB JTC Budget Guidance 2025” attached for further details.

Note: The ERDERA JTC2025 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 latter does not apply to contract researchers, as outlined above.

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. Where candidates for a Master’s degree are proposed to work on projects, Lead Applicants must carefully consider:

• The complexity, scale, objectives, and dependencies of the project.
• The suitability of such project in terms of delivering a clearly identifiable original research project or the potential difficulties in clustering various pieces of work packages for a Master’s thesis. The skills, expertise and experience level required to carry it out.
• Any requirements and/or restriction relating to the Master’s candidate’s registration with the Host Institution, and this should be accounted for when determining the start date of the award.

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. Please refer to the Joint Transnational Calls section of the ERDERA funding 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 following will apply to partners seeking HRB funding – i.e., Lead Applicants.[4] If there is more than one Irish partner/coordinator and they are based in different Host Institutions (see below), they must apply as separate partners.

Where more than one Irish coordinator/partner exists, each must meet the Lead Applicant eligibility criteria. However, the HRB will only contract with the Host Institution of one Lead Applicant (this must be the coordinator if an Irish coordinator exists).[5] This 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 the second Irish partner via collaboration and/or consortium agreements.

Early Career Researchers (ECRs) are encouraged to join consortia as full research partners. ECRs based in Ireland should refer instead to the eligibility criteria below.

Each applicant can participate in more than one application but can only one be a coordinator on one.

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 ‘How to apply’ 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 ‘How to apply’ 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 but it may be another organisation/institution designated by the research team, where it is clearly justified. 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.

[4] In view of the overwhelming evidence that both active and passive smoking of tobacco are injurious to health, the HRB is unwilling to fund applications from individuals applying for, holding, or employed under a research grant from the tobacco industry.

[5] For administrative purposes, the second partner will be recorded in HRB systems as a Co-Applicant.

Early career researchers (ECRs) eligible for this scheme are postdoctoral researchers from different disciplines who are engaged in health-related research activities typically in academic or other research institutions.

ECRs are those who have already consolidated their research knowledge, skills, methodologies and capabilities through a period of mentored postdoctoral research and who are currently progressing towards becoming independent researchers.

ECR Lead Applicants must be able to demonstrate they have the skills, knowledge and supports necessary to direct the proposed research and to carry the research through to completion by showing:

• Appropriate evidence of expertise matching the nature and context of the project;
• A track record of contribution to scientific knowledge demonstrated by relevant research outputs that can prove they are ready to transition to research independence;
• Some experience, capability and authority to supervise researchers (e.g. early stage researchers, research assistants, other health and care practitioners);
• A track record in independently peer-reviewed grant funding. This may include being Lead Applicant on personal awards and/or fellowships and/or being listed as co-applicant and/or collaborator on any other type of research grant.

Qualifications

The ECR Lead Applicant must have:

• a PhD or
• have been granted PhD equivalence by the HRB (are proven to have at least four years of active research experience post-primary degree).

Note: PhD equivalence must be granted by the HRB before the call submission date and will not be considered after application submission. Contact HRB in relation to this approval process. PhD equivalence can be granted only to individuals who are not undertaking a PhD at the time of submission. Individuals currently studying for a PhD are ineligible to apply to this funding call. This includes individuals who have research experience prior to starting their PhD.

Note: Active research experience will be considered when assessing eligibility by the HRB and competitiveness of the track record of the Lead Applicants by reviewers. Career breaks, flexible working arrangements, changes in discipline and sector (e.g. industry, health organisation/agency) will be taken into account when assessing the research experience and scientific contribution to knowledge.

Career stage

The ECR Lead Applicant must have at least four years and up to seven years active post PhD (or equivalent) research experience. Where this is based on PhD equivalence, this should be taken from the date at which PhD equivalence is considered by the HRB to be achieved (the end of the four years referenced above).

For the purposes of this call the official date of a PhD is defined as the year that the dissertation was successfully defended. Gaps (e.g. career breaks, flexible working arrangements) should be deducted when calculating the years of active post PhD (or equivalent) research experience.

Employment history

The scheme is open to individuals who have the support of a HRB approved Host Institution in the Republic of Ireland.

The ECR Lead Applicant must:

• hold a fixed term post-doctoral or other research-based positions that covers the duration of the award or
• be an individual who will be recognised by the Host Institution upon receipt of the ERDERA JTC2025 award as a post-doctoral researcher as defined above

AND

• be requesting a maximum of 0.5 FTE of their own salary related costs or
• not request their own salary

A letter of support will be required for contract positions (see ‘How to apply’ below).

There will be a two-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 13:00 GMT on 13 February 2025 via the proposal submission system. No other means of submission will be accepted.

For further details, please refer to the respective submission forms available through the Joint Transnational Calls section of the ERDERA funding 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:

• New applicants to HRB’s Joint Transnational Calls must demonstrate that they meet the eligibility criteria by completing the Lead Applicant eligibility form by the submission deadline. This does not apply to previous applicants to JTCs.
• Host Institution Letters of Support must be provided for (1) all named Lead Applicants in a contract position and (2) Adjunct Professors not directly employed by the HI. These must be emailed to HRB-JTCs@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:

1. Case (1): [Host Institution – insert name] which is the host institution of [applicant – insert name] confirms that [applicant – insert name]: (i) holds an employment contract which extends until [insert date] or will be recognized by the host institution upon receipt of the HRB [scheme] award as a contract researcher; (ii) has an independent office and research space/facilities for which they are fully responsible for at least the duration of the award, and (iii) has the capability and authority to mentor and supervise the research team.
2. Case (2): [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):

DLR Projektträger (DLR-PT, Germany)

Dr Katarzyna Saedler, Dr Michaela Fersch and Dr Ralph Schuster

Email: SelteneErkrankungen@dlr.de

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

Dr Siobhán Hackett

Email: HRB-JTCs@hrb.ie