Code of Conduct

Ethics

INTERVENE recognises the multiple ethical and social implications of the medical use of PRSs ranging from social and distributive justice questions to debates on their scientific validity and clinical utility. Moreover, and importantly, the project considers the ethical and social aspects of PRSs and AI ethics together. INTERVENE includes a work package dedicated to ethics, where we ask how the challenges of applying PRS and AI in medicine should be addressed ethically. We take on an embedded ethics approach, where the research strives to address ethics in a comprehensive and responsible way throughout the project. This means that we are tuned in to the emerging complexity regarding fairness, challenges in building trust, explaining and understanding artificial intelligence and polygenic risk scores as well as regulatory uncertainties and further challenges.

Data management

Use of existing data: INTERVENE is primarily concerned with the secondary use of data and metadata collected to biobanks in the US and in Europe. The data contained in these repositories and used by INTERVENE has been collected under conditions fulfilling necessary local ethical and legal requirements before or during the project period. Utilization of this data by INTERVENE members builds on the sending of computational tasks to the biobanks and -repositories for local processing. Personally identifiable information is pseudonymized and transferred to the research partners on an aggregate level with no individual-level data identifiable. The personal data contained in the biobanks will at all times remain under the control of the biobanks and for the majority of these will not leave their own infrastructure, meaning INTERVENE complies with the terms of mode of access mandated by these biobanks.

New data generated by the project: INTERVENE generates new methods and algorithms for AI-based data analyses and the development of genetic risk scores. In addition, two clinical pilot projects collect new individual level clinical, questionnaire and (gen)omics data, and separate ethics committee/Institutional Review Board approvals have been obtained for these collections. These personal data are not shared outside the partners.

Data security: The technological framework developed in INTERVENE for the secure access and exchange of cross-border genomics, -omics and longitudinal health datacomplies with national regulations and GDPR.