A pillar refers to a thematic vertical research area that focuses on a specific scientific domain or subject matter. Each pillar includes its own research objectives, activities, and dedicated experts. Pillars provide the disciplinary depth needed to address complex issues in health and biomedical data, and new pillars can be added as the cluster evolves.
Biomedical imaging at the University of Malta focuses on the utilisation of advanced imaging technologies to facilitate ground-breaking research in medical science. This pillar supports the enhancement of diagnostic precision and the exploration of new therapeutic avenues across various medical disciplines.
Enhance Diagnostic Techniques: Utilise advanced MRI and other imaging modalities to improve the accuracy and early detection of diseases such as cancer, cardiovascular diseases, and neurodegenerative disorders.
Facilitate Interdisciplinary Research: Foster collaboration between imaging scientists, clinicians, and researchers from other disciplines to integrate imaging data with genetic, clinical, and epidemiological data.
Develop Innovative Imaging Solutions: Pursue technological advancements in imaging, including AI and machine learning algorithms, to process and analyse imaging data more effectively.
Develop Legal and Ethical Frameworks: Establish robust frameworks to ensure ethical collection, storage, and use of imaging data, in alignment with GDPR and other regulations.
Infrastructure Development: Enhance the MRI Research Platform (UMRI) and other imaging facilities to support high-quality research.
Training and Workshops: Offer specialised training sessions and workshops for researchers and students in imaging techniques and data analysis.
Collaborative Research Projects: Engage in partnerships with international research institutions and industry leaders to advance imaging technologies and applications.
Policy Development: Work on creating and refining policies that govern the ethical use of medical imaging in research and clinical settings.
This pillar addresses the critical aspects of genetic research and the management of biobanks, focusing on the ethical, legal, and scientific challenges related to the collection and use of genetic data.
Expand Biobank Resources: Strengthen the capacity of DwarnaBio and other biobanking facilities to support a wider range of research initiatives.
Enhance Genetic Research Capabilities: Advance the understanding of genetic markers that influence health and disease, particularly those prevalent in the Maltese population. Develop Legal and Ethical Frameworks: Establish robust frameworks to ensure ethical collection, storage, and use of genetic data, in alignment with GDPR and other regulations.
Biobank Integration: Enhance interoperability between biobanks and other data resources to facilitate comprehensive data analysis.
Research on Genetic Diseases: Support studies focused on the genetic basis of common and rare diseases, aiming to develop targeted therapies.
Policy Development: Work on creating and refining policies that govern the ethical use of genetic information in research and clinical settings.
A horizontal refers to a cross-cutting area of focus that spans across all pillars. Horizontals address overarching themes or support functions necessary to integrate and connect the work done within the pillars. Horizontals provide the legal, ethical, technological, and societal scaffolding to ensure the cluster operates cohesively and responsibly.
Horizontal One aims to:
Horizontal One aims to survey the current laws and practices within selected EU Member States and the UK. The initial focus will be on the currently activated pillars one and two, specifically in relation to the processing of health, biometric, and genetic data for scientific research purposes.
We intend to promote the access to and reuse of health data for scientific research in a manner that upholds privacy, security, transparency, trust, and efficient governance.
Our goal is to identify and assess the state of Maltese legislation and practices regarding the processing of health, biometric, and genetic data. This will create a thorough understanding of what is currently available, thus building a solid foundation for us to base our work on.
We will explore the acceptability and limitations of ‘explicit consent’ as a legal basis for data processing, in accordance with Article 9(2)(a) of the GDPR. This will also involve consideration of alternative consent models such as tiered, dynamic, and meta-consent.
We aim to assess the applicability of the exemption in Article 9(2)(j) of the GDPR, which allows for alternative legal bases for data processing provided there are 'suitable and specific measures' to protect data subjects' fundamental rights and interests.
We seek to evaluate the preferable legal basis for data processing that effectively balances the protection of data subjects' privacy-related interests with the goal of advancing scientific research.
Our objective is to monitor the implementation and effects of the model legislation and/or standard data protection clauses proposed under PaDME and intended to regulate data processing by local research institutions.
DISC will contribute to the proper application of the GDPR by drafting relevant codes of conduct for application by research bodies, taking into account the specific features of the research sector and the needs of micro, small and medium-sized project teams and, or consortia.
We aim to identify and work towards removing legal obstacles that impede the sharing of data in the context of scientific research.
Horizontal Two aims to:
The primary aim of Horizontal Two is to allow scientific research to begin on health and biometric data collected from UM's MRI scanner. We aim to provide an appropriate legal basis for data processing that aligns with all applicable regulations and promotes robust scientific research.
We plan to offer support to the UMRI Platform, ensuring that it operates effectively and in compliance with all data protection legislation. This includes providing guidance on data handling and sharing, in line with current best practices and regulatory requirements.
Our aim is to extend our support to DwarnaBio, assisting in their operations within the boundaries of the law and ethical guidelines. Our support will include guidance on data protection, best practices for data handling, and strategies to enhance their research productivity while ensuring adherence to all relevant data protection regulations.
We aim to foster collaboration between scientists (biological and social), legal experts, and technology experts, promoting a more comprehensive and interdisciplinary understanding of data handling and protection in scientific research. This will include organising workshops and seminars to foster knowledge exchange and collaborative learning.
We aim to promote open science practices by publishing scientific articles and sharing datasets in the fields of imaging and genomics. Our aim is to contribute to a more transparent and collaborative scientific community, thereby advancing knowledge more effectively.
We plan to curate, publish, and share at least three datasets in the disciplines of imaging and genomics. This will provide valuable resources for further research and facilitate a more efficient and collaborative approach to scientific inquiry. Specifically, DwarnaBio aims to establish and make available to researchers a reference Maltese Genome database that can empower rare disease research and medical diagnostics. Concurrently, UMRI is developing a digital imaging bank specifically designed to enhance medical imaging diagnostics.
Our objective is to employ advanced analysis techniques such as machine learning and AI to drive forward scientific research. By leveraging these technologies, we aim to enhance our understanding of complex datasets and accelerate scientific discovery.
Horizontal Three aims to:
Our primary aim is to design and develop technological infrastructures that inherently respect and uphold data protection principles, such as transparency, security, and accountability, whilst providing increasing visibility and access to the available data. We seek to ensure these core principles are integrated into the system 'by design'.
We intend to address and eliminate technical barriers that hinder data sharing. Our focus is on promoting interoperability, which allows seamless data exchange and interpretation across various systems and platforms. This involves the development of specialising Application Programming Interfaces (APIs) that would allow machine-to-machine communication, as well as appropriate interfaces that allow users to browse and search for relevant data. By promoting data interoperability, we aim to contribute to the establishment of a cooperation framework both within Malta and across the European Research Area. This framework will facilitate secure data exchange and collaboration in scientific research.
We plan to provide the necessary technical mechanisms to allow researchers to cooperate more effectively, exchange information, and share data across borders, sectors, and organisational boundaries.
We aim to work towards the creation of shared digital solutions. This includes the development of open-source software, guidelines, checklists, frameworks, and IT tools that facilitate and streamline data sharing and processing in a secure manner. Moreover, the availability of datasets of sufficient sizes allow research and application of data-driven techniques, including the utilisation of Artificial Intelligence and Machine Learning on the available datasets.
We plan to actively contribute to European Union initiatives in these fields, particularly those promoting the establishment and maintenance of a single European Research Area. One of DwarnaBio goals is to provide samples for the European 1+ Million Genomes initiative, which aims to enable secure access to genomics and the corresponding clinical data across Europe for better research, personalised healthcare and health policy making.
One of our key objectives is to conduct in-depth research into anonymisation and de-identification techniques. We will focus on ensuring information security, improving existing anonymisation techniques, and contributing to the overall robustness and reliability of anonymisation processes. This will enhance the balance between data utility and privacy in data-driven research.
Horizontal Four aims to:
The notion of public trust and legitimacy is particularly crucial in the field of biobanking practices and research. The success and sustainability of biomedical research depends on the participation and cooperation of patients, and also of the general population, whose samples and data are collected and shared within the research community. There are, however, potential hazards entrenched in the action of sharing personal data - principally the potential breach of data security which may lead to stigma and discrimination. Other key areas of concern include concerns associated with vested interests of the researchers related to prestige and profit; the potential misuse of data, results and technology , and the potential sharing and use of research data for unethical purposes unrelated to the original biobank donation.
2. Explore beliefs and attitudes of the Maltese general public and also local rare disease patient community, related to sharing of samples and data:
Our aim is to contribute towards policy and governance best practices by providing qualitative and quantitative sociological data on the beliefs and values related to collecting and sharing of biomedical samples and data for research, in the Maltese context.
PPI presents an opportunity to engage with the public(s), understand their concerns, and incorporate their feedback into the design, operation and governance of biobanking research.
One way researchers work collaboratively with lay members is through the establishment of community advisory panels (CAP). Membership usually consists of lay stakeholders with a diversity of backgrounds and perspectives. Meaningful PPI occurs when CAP members, who are treated as research partners, are involved in a sustained manner throughout the project.
