Operational Integrity
Ethics Framework of the UNCAN-CONNECT Project
The UNCAN-Connect project is guided by a comprehensive framework designed to support responsible research practices, transparency, and respect for fundamental rights throughout the entire project lifecycle.
Governance & Oversight
Dual Governance Structure
A core element of the project is its commitment to operating in accordance with relevant legal and ethical requirements at both EU and national levels. Ethical governance is supported through structured internal procedures together with the involvement of an independent external Ethics Advisory Board.
The Board provides expert advice and independent oversight, reviewing ethical practices, offering guidance on emerging issues, and monitoring alignment with approved standards. By recommending corrective measures where appropriate, this dual structure ensures accountability and transparency while supporting public confidence in the project’s objectives and methods.
Stakeholder Engagement
Identification of ethical questions through engagement with researchers, clinicians, technical developers, and patient representatives.
Design Principles
Technical development follows privacy-by-design and security-by-design principles, embedding safeguards into the architecture.
Data Utilization
Federated & Decentralised Model
A distinguishing feature of the project’s technical and ethical approach is the adoption of a federated, decentralised model for data utilisation. Within this model, data generally remain under the stewardship of their originating institutions while still enabling collaborative analysis across borders.
This approach reduces risks associated with centralised storage and reinforces institutional responsibility for data management while strictly adhering to GDPR principles (accountability, transparency, confidentiality, and data minimisation).
Data Protection
Controlled access mechanisms are applied where feasible to protect sensitive health and research data.
Participant Rights
Rights of access, rectification, and erasure are preserved for all participants in line with applicable legislation.
Clinical Integrity
Human Biological Materials
Research involving human biological materials, such as tissues and cell samples, is approached with particular ethical attention. The UNCAN-CONNECT consortium recognises that the use of such materials raises significant considerations related to consent, privacy, traceability, and the potential for misuse.
Our framework ensures that research-oriented activities, particularly those connected to cancer-related use cases, receive particular scrutiny due to the sensitivity of the materials involved and their potential societal implications.
- Informed consent sought prior to collection or use.
- Materials used solely for ethically approved purposes.
- Required accreditations and authorisations obtained before use.
- Samples handled via secure and traceable procedures.
- Documentation of origin to support transparency.
- Collaboration with institutional and national ethics committees.
Autonomy & Compliance
Informed Consent & Approvals
The process is designed to be clear, inclusive, and respectful of participant autonomy. Consent forms and information materials are prepared in accessible language and made available in relevant local languages.
Participants are informed about the nature and purpose of the research, the intended use of their data/materials, and their right to withdraw at any time without negative consequences.
Protection of Vulnerable Populations
Particular care is taken when involving vulnerable populations, such as minors. In such cases, consent is obtained from parents or legally authorised representatives who receive sufficient information to make decisions on behalf of the child. Individuals who are unable to provide valid informed consent are not enrolled in research activities.
All clinical and research activities involving human participants are subject to formal ethics approval procedures. Each participating clinical institution seeks approval from its relevant local or national ethics committees prior to initiating studies.
Monitoring and auditing mechanisms are established to support continued compliance. The project conduct is informed by widely accepted benchmarks:
- Declaration of Helsinki
- CIOMS Guidelines
- WHO Standards
- Council of Europe Convention
- EU Clinical Trials Regulation
- GDPR
Core Philosophy
A Reflective Approach to Innovation
The UNCAN-Connect project integrates ethical considerations as an ongoing process that accompanies the entire project lifecycle. This orientation is informed by internationally recognised declarations and conventions that provide widely accepted benchmarks for responsible research conduct.
Research with Integrity
By integrating robust governance mechanisms, proactive stakeholder engagement, and transparent data practices, the UNCAN-CONNECT project ensures that groundbreaking cancer research always recognizes the primary importance of individual rights and societal expectations.