Ethics guidance report. Ethics Impact Assessment

Project Full Title: AcceleRating the Translation of virtual twins towards a pErsonalised Management of steatotic liver patients
Project acronym: ARTEMIs
Project type: Horizon Europe | RIA (Topic HORIZON-HLTH-2023-TOOL-05-03)
Grant agreement no: 101136299

The overall objective of the ARTEMIs project is to develop and demonstrate the feasibility of a clinical decision support system (CDSS) for use in the clinical management of metabolic steatotic liver disease (MASLD is the new nomenclature, previously MASLD). The CDSS aims to provide clinicians with clinically meaningful information for more personalised management of MASLD patients. Such developments require representative, multi-domain and multi-centre patient data. The ARTEMIs cohort is a key component of the project, with eleven participating clinical research centres from France, Spain, Germany, Belgium, Austria, Italy and the UK.

This deliverable aims to define the project’s ethical framework and ensure ethical compliance in conducting the cohort study, using personal data in the research activities, and designing and implementing an ethical ARTEMIs CDSS.

This report will propose a comprehensive ethical framework for developing and evaluating virtual twin technology in liver disease. It will define ethical guidelines, including assessment frameworks, for project participants to verify compliance with ethical standards related to patient consent, privacy, data security and responsible use of AI. Task 1.5 – Ethical Requirements will oversee compliance with the ethical guidelines defined here, thereby ensuring patients’ rights and promoting an ethical approach to VT-based patient management solutions by design and by default.