Ethical, legal and equity considerations

WP12 tackles the ethical, legal, and social implications (ELSI) of implementing personalised cancer medicine (PCM) across Europe. It addresses regulatory diversity, equity challenges, and societal vulnerabilities, ensuring patient-centred approaches and alignment with EU regulations. WP12 analyzes existing use cases, guidelines, frameworks, and best practices to generate ELSI tools prioritizing patient-centered approaches to reflect their values, preferences, and needs. Specific attention will be given to developing standards for cross-border collaboration, supporting data sharing, and harmonizing approaches across regions and member states and connecting them with patients' perspectives and shared decision-making.

Leading organisation
Co-leading organisation
Tasks

Task 12.1: Integrating ethical, legal, and social implications into joint action personalised cancer medicine

Develop a practical ethical, legal, and social implications FAQ guide to ensure ethical, legal, and social implications are consistently addressed across all work packages. Conduct regular assessments of project activities to identify and resolve ethical, legal, and social implications challenges. Efforts will be streamlined to avoid redundancy and foster collaboration and synergy between work packages and related initiatives, including a mapping exercise of existing frameworks.

Leading organisation
Co-leading organisation

Task 12.2: Inequalities and societal implications of personalised cancer medicine

This task will address new inequalities arising from personalised cancer medicine implementation. It will identify strategies to tackle individual perspectives, novel decisional challenges, and social/cultural values that promote effectiveness or participation in personalised cancer medicine. It will raise awareness of new vulnerabilities in personalised cancer medicine. It will provide support materials for shared decision-making and informed consent in personalised cancer medicine.

Leading organisation
Co-leading organisation

Task 12.3: Sharing data and scaling genomic platforms and remote services

Developing ethical and legal frameworks for secure data sharing and analysis, protecting patient confidentiality in remote genetic counseling, and scaling genomic platforms in compliance with data protection standards, such as the General Data Protection Regulation. Efforts will include mapping of culturally adapted information and consent processes, enhancing equity in access to remote services and secure data processing.

Leading organisation
Co-leading organisation

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