A roadmap towards Ireland’s membership of BBMRI-ERIC

Abbreviations

BBMRI-ERIC – Biobanking and Biomolecular Resources Research Infrastructure - European Research Infrastructure Consortium

BnaG – BioBANC na Gaillimhe

CRF – Clinical Research Facility

DOH – Department of Health

EATRIS-ERIC – European Infrastructure for Translational Medicine - European Research Infrastructure Consortium

ECRIN – European Clinical Research Infrastructure Network

EHDS – European Health Data Space

ERIC – European Research Infrastructure Consortium

EU-AMRI – European Union Alliance for Medical Research Infrastructures

GDPR – General Data Protection Regulation

HRCI – Health Research Charities Ireland

HRB – Health Research Board

HSE – Health Service Executive

IARC – International Agency for Research on Cancer

INAB – Irish National Accreditation Board

IPPOSI – Irish Platform for Patient Organisations, Science and Industry

ISBER – International Society for Biological and Environmental Repositories

NBWG – National Biobanking Working Group

NCTO – National Clinical Trials Office

NREC – National Research Ethics Committees

NSAI – National Standards Authority of Ireland

PFM – Personalised Functional Medicine

PPI – Patient and Public Involvement

WHO – World Health Organisation

Introduction

Biobanks are the cornerstone of biomedical research and healthcare delivery as medicine becomes increasingly personalised. For common complex diseases such as cancer, much of our insight into the causes and treatment of disease has come from analysis of clinical samples. BioBANC na Gaillimhe (BnaG) is a multidisciplinary initiative based at the School of Medicine, University of Galway, that brings together expertise in biobanking to foster an inclusive, patient-centered, and efficient research environment¹. The third annual BioBANC Symposium held at the University of Galway on 6th September 2024, brought together experts and advocates from the Irish biobanking, clinical research, healthcare, industry, and patient advocacy communities. Central to the discussion was Ireland’s membership of Biobanking and Biomolecular Resources Research Infrastructure - European Research Infrastructure Consortium (BBMRI-ERIC), the European Research Infrastructure dedicated to strengthening biomedical research by supporting networked and standardised biobanking practices and policies across Europe in the provision of structured access to quality aligned samples and data².

In a welcome address, Professor Michael Kerin, Chair of Surgery, University of Galway, Director of the Health Service Executive (HSE) West and North West Cancer Network and Vice President of the Royal College of Surgeons in Ireland ardently championed the patient’s voice highlighting the challenges of delivering cancer care, recruiting participants for biobanking and clinical trials amid the constraints of the General Data Protection Regulation (GDPR) and the impracticalities of reconsent. He also commented on the importance of biobanking as a key enabler in personalised medicine and advances in cancer care. This prefaced a workshop “Pathway to Ireland joining BBMRI-ERIC” with keynote presentations by Professor Jens Habermann, Director General of BBMRI-ERIC and Dr Eva Ortega-Paino, Secretary General for Research, Ministry of Science, Innovation and Universities, Spain (Table 1).

In an opening presentation titled “Setting the Scene of Biobanking in Ireland”, Oonagh Ward, Head of Research and Innovation Infrastructures, Health Research Board (HRB) outlined previous Irish biobanking position papers and why biobanking infrastructure in Ireland has failed to date. Reference was made to the HRB’s commitment to biobanking as a key action in the HRB strategy 2021–2025 to: “Take a leading role to convene stakeholders to progress the design, development and implementation of national, shared high-cost research infrastructures, including in the areas of biobanking and genomic research”³. A vision towards BBMRI-ERIC membership was signposted using experience from the strategic investment in clinical trials in Ireland to standardise expertise and delivery through membership of the European Clinical Research Infrastructure Network (ECRIN) within the European research infrastructure (ERIC) for clinical trials as precedence.

Professor Jens Habermann, Director General of BBMRI-ERIC, highlighted the extensive capabilities of the BBMRI-ERIC network in his keynote address, “Connecting Ireland to Europe's Biobanking and Biomolecular Resources Research Infrastructure.” As one of the largest distributed research infrastructures, with its headquarters in Graz, Austria, BBMRI-ERIC represents almost 500 biobanks across 25 Member and Observer countries, including the International Agency for Research on Cancer (IARC)/World Health Organisation (WHO). It offers scientific services for ethical, legal and societal issues, quality management, IT services, biobanking development, and provides central services and functions such as finance and project management, public affairs, and outreach, education and communications. It furthermore operates the world’s largest biobank catalogue – the BBMRI-ERIC Directory.

The scale of BBMRI-ERIC’s connectivity to a vast network of partners and EU initiatives illustrates its extensive reach. This network includes the ERIC Forum, which is administratively supported by BBMRI-ERIC, and other European Research Infrastructures in the field of health and life sciences. With a coordinating role in projects relating to EU priorities such as EU Mission on Cancer or further strengthening of Research Infrastructures and ERICs, as well as an important role in other projects, BBMRI-ERIC is contributing its core expertise towards structuring the European Research Area. In this respect, BBMRI-ERIC’s federated access and analysis platform has become a strong asset and reference point for EU initiatives such as the European Health Data Space (EHDS) and EUropean Federation for CAncer IMages (EUCAIM) and serves as an example of the impact of BBMRI-ERIC core expertise on EU health and life science research developments.

BBMRI-ERIC’s new 10-Year Roadmap, including its vision, mission and strategic objectives, was outlined, emphasising a One Health approach in biobanking (Figure 1). This One Health concept, driven by WHO, is an integrated unifying approach recognising that the health of humans, animals, plants, and the wider environment are closely linked and inter-dependent.

Figure 1. BBMRI-ERIC's 10-Year Roadmap overview.

Dr Ortega-Paino’s keynote “Sharing is caring: the case of BBMRI Spain”, outlined Spanish research infrastructure and Spain’s involvement in European research infrastructure programmes. Underscoring Spain’s strategic positioning in research infrastructure and its commitment to advancing biobanking through collaboration, quality assurance and innovation, Spain joined BBMRI-ERIC as an observer in 2021, with active participation in working groups and task forces. BBMRI-ERIC observer status is granted for a maximum period of three years, after which Spain will request full membership from the BBMRI-ERIC Assembly of Members. Dr Ortega-Paino reported the benefits of BBMRI-ERIC membership for Spain’s research landscape, including improved data quality, ethical compliance, and streamlined access to research samples and infrastructure. This membership supported enhanced collaboration and integration with EU research networks.

Opening a panel discussion on "Future of Irish Biobanking Community - Roadmap towards BBMRI-ERIC Membership", Dr Sonja Khan, Head of Education at the Institute for Clinical Trials, University of Galway, presented a survey of biobanking practice in Ireland. The study identified 36 biobanks, mostly in Dublin, followed by Galway and Cork, with the majority linked to academic or non-profit institutions and focused on disease-specific research, particularly cancer. The study highlighted infrastructural gaps in the Irish biobanking community, in particular the lack of a national biobanking registry and concluded that a comprehensive biobank registry would enhance transparency and inform government funding⁴. These findings align with the Health Research Charities Ireland (HRCI) November 2023 report recommending a thorough review of Ireland's biobanking landscape⁵.

A discussion, exploring Ireland’s potential membership of BBMRI-ERIC followed. Panellists included Mr Billy McCann, a Patient and Public Involvement (PPI) representative and graduate of the Irish Platform for Patient Organisations, Science and Industry (IPPOSI); Dr Avril Kennan, HRCI, Prof Fai Ng, HRB Clinical Research Facility (CRF) UCC, Orlaith Gavan, Pfizer Healthcare Ireland, Dr Robert O’Connor, National Clinical Trials Office (NCTO) Dr Eva Ortega-Paino, Spain and Prof Jens Habermann, BBMRI-ERIC (see Table 1 for full details of speaker affiliations). The discussion was hosted by Emma Snapes, BioConsulting, Cork.

Methods

Discussions and outcomes from the panel were captured and reproduced with consent from the participants and thematic analysis was conducted to identify key themes related to the benefits, gaps, and strategic imperatives for enhancing Ireland’s biobanking framework. Panel participants and speakers provided consent for their contributions to be included in the study analysis.

Questions for the panel were prepared by the BioBANC na Gaillimhe organising committee ahead of the symposium, to guide discussions towards achieving strategic goals. During the discussion, VEVOX live polling was used to gauge audience views and questions on posed topics, enabling interactive audience participation and capturing real-time feedback to enrich the discussion. Responses to the question "What steps can be taken to better map the Irish Biobanking landscape?" were visually summarised in a word cloud (Figure 2), highlighting key themes such as legislation, funding, and public outreach as important in shaping the future of Irish biobanking.

Figure 2. Word cloud of responses to 'What steps can be taken to better map the Irish Biobanking landscape?'

Results

Discussion

The panel emphasised the need for a strategic approach to overcome legislative and procedural challenges in Irish biobanking. Aligning with European standards and pursuing BBMRI-ERIC membership were discussed as key steps. These measures would enhance research capabilities and enable more effective, personalised healthcare solutions.

A vision for a diverse and inclusive Irish biobanking network was also highlighted, stressing the importance of representing all population segments to ensure comprehensive and impactful health research in a multicultural society. The panel advocated for immediate and proactive steps towards integrating into the European biobanking framework through BBMRI-ERIC. This approach is a vital step toward standardisation, collaboration, and advancing Irish healthcare, representing a commitment to patients, researchers, and industry partners.

The panel’s consensus was clear: Ireland’s healthcare and research infrastructures would benefit greatly from the integration, standardisation, and collaborative opportunities that BBMRI-ERIC membership provides. For Ireland, joining this network is not merely an opportunity; it is an obligation to the patients, researchers, and industry partners who are committed to advancing Irish healthcare. Joining BBMRI-ERIC is a decisive step toward fulfilling this commitment, and Ireland is poised to make that leap, equipped with the support of its dedicated stakeholders and a unified vision (Figure 3).

Figure 3. Key takeaways from the BnaG panel discussion.

Audience polling revealed strong support for Ireland joining BBMRI-ERIC, with 100% of respondents in favour and 75% willing to provide contact details for further engagement. Stakeholders’ primary interest lay in biobanking’s future, with 60% from academia, 14% from government agencies, and 7% each from hospitals and charitable organisations. This highlights the interdisciplinary nature of biobanking, uniting healthcare, regulatory, and non-profit sectors. The unanimous support underscores the community’s commitment to strengthening Ireland’s biobanking infrastructure and its international research role. It should be noted that polling results reflect the views of participants who attended the symposium and may not represent the entire Irish biobanking landscape.

This engaging exchange reinforced a shared commitment among stakeholders to strengthen Ireland’s biobanking capabilities and prioritise membership in BBMRI-ERIC, a pivotal step in fostering international collaboration and advancing healthcare outcomes. Joining BBMRI-ERIC is seen as essential for aligning Ireland’s biobanking infrastructure with global standards, improving patient care, and unlocking broader research and economic opportunities.

The session on "Quality Matters" highlighted the importance of standards and best practices in biobanking. Linda Hendy from the National Standards Authority of Ireland (NSAI) and William Clarke from the Irish National Accreditation Board (INAB) emphasised the critical roles of standardisation, accreditation, and compliance in ensuring the credibility of biobanking operations and fostering international collaboration. Dr Nicola Miller and Dr Oliver Carroll (University of Galway) outlined International Society for Biological and Environmental Repositories (ISBER) Best Practices^9,10 and the value of proficiency testing in maintaining material fitness and enhancing performance, respectively. The ISBER-endorsed Biospecimen Proficiency Testing Program, provided by the Integrated Biobank of Luxembourg (IBBL) enables biorepositories to benchmark their performance against global peers, meet accreditation standards (e.g., ISO 20387, ISO 17025, CLIA), and continuously monitor and improve testing and processing accuracy^11,12. Jack O'Grady (My Green Lab) discussed promoting environmental sustainability in laboratory operations.

Biobank Ireland Trust is an independent national charitable initiative that supports the development of biobanking throughout Ireland, with a particular focus on cancer research¹³. Prof Richard Flavin (Trinity College Dublin/St James’s Hospital, Dublin) showcased Biobank Ireland Trust’s efforts in providing high-quality tissue samples for cancer research and fostering a federated biobank network, advocating for PPI and ethical governance. Prof Seán O. Hynes (University of Galway/University Hospital Galway) concluded the session by reaffirming the commitment to advancing research, improving healthcare outcomes, and solidifying Ireland’s role in the global biobanking landscape.

Conclusion

BioBANC Symposium III demonstrated the strong support for networked biobanking and BBMRI-ERIC membership from the stakeholders in Ireland’s biobanking community, patient advocacy groups, and the pharmaceutical industry. The infrastructural support is crucial for strengthening the foundation of biobanking in Ireland and enhancing its impact on global biobanking practices. Furthermore, there is a critical need to address human capital gaps to facilitate the activation of BBMRI-ERIC membership and ensure preparedness upon approval.

Membership in BBMRI-ERIC would align Ireland with leading European research infrastructures, enhancing its research capabilities and fostering international collaborations. It would also promote higher standards and economic growth through improved research infrastructure. The discussions and strategies outlined at the symposium provide a roadmap for advancing Ireland’s biobanking capabilities to effectively meet current and future health research challenges.

“BioBANC Symposium has become an essential platform for bringing together the specialised community of Irish biobanking professionals. As biobanks continue to evolve, they are playing an increasingly critical role in advancing healthcare and addressing some of the world’s most pressing health challenges. This evolution is bringing changes in the relationship between biobanks and the biological samples and data they are entrusted to preserve by patients and participants. The Irish biobanking community is advocating that these changes are best navigated in alignment with our European partners through membership of BBMRI-ERIC. Láidir le chéile”.

Dr Nicola Miller, Dr Sonja Khan – BioBANC na Gaillimhe

“BBMRI-ERIC membership significantly enhances member states’ health research capabilities by providing access to resources of almost 500 biobanks, while ensuring adherence to biobanking standards and ethical, legal and societal aspects. Ireland's membership would align with the BBMRI-ERIC 10-Year Roadmap "Biobanking for a Healthier World," which aims to unlock the potential of biobanking and biomolecular resources to inspire the best research for the benefit of patients, the public, and the planet. We therefore hope for Ireland to join our community.”

Prof Jens K. Habermann – Director General, BBMRI-ERIC

“A huge job of education needs to be done in the context of the general public. People want to contribute to research, but they need to better understand how their contributions make a difference”

Mr Billy McCann – PPI Member NBWG, NREC for Medical Devices, IPPOSI graduate.

"We simply owe it to our patients. We are not doing anywhere close to enough. For patients, when they attend our hospital and social care services, and if research is embedded, that could be completely different. Let's just get on with it."

Dr Avril Kennan – CEO Health Research Charities Ireland (HRCI)

“Pfizer invests a significant amount in Ireland and recognises the importance of biobanking, which is why it is built into all clinical trials. To maintain Ireland’s position in oncology, we simply must improve, if we are to continue to position Ireland as world class”.

Orlaith Gavan – Chief Medical Officer, Pfizer Healthcare, Ireland

"We need to involve all stakeholders - patient representatives, scientists, clinicians, industry, and the public - to leverage existing expertise, tools, and innovation, creating new synergies. We must move beyond working in silos to fully leverage resources and expertise. This is crucial as we face dramatic global challenges; we cannot afford to waste these resources."

Prof Jens K. Habermann – Director General, BBMRI-ERIC

“We in University of Galway are fortunate to have our translational research facility and biobank co-located with the main teaching hospital and cancer centre in the West and Northwest of Ireland. As Director of the regional Cancer Network, biobanks and multidisciplinary teams working across hospital and academia are essential to enabling patient focused research. I am delighted to see this BioBANC Symposium taking place, encouraging collaboration and knowledge exchange between researchers, clinicians, educators, and members of the public.”

Prof Michael Kerin – Chair of Surgery, University of Galway (formerly NUI Galway), Director of the HSE West and North West Cancer Network and Vice President of the Royal College of Surgeons in Ireland.

Ethics and consent

The manuscript reports on a panel discussion held during the BioBANC Symposium, which featured invited experts discussing publicly available information and their professional opinions. As this was a symposium rather than a study involving the systematic collection of data from human subjects, no formal ethical approval was required. The format of the panel discussion did not involve interventions with or treatments of human subjects as defined under the Declaration of Helsinki, nor did it include any personal or sensitive data subject to ethical oversight.

Consent for including the names and contributions of the panellists was obtained. All panellists were contacted via email and agreed to have their discussions and professional opinions included in the report.