D4.9 2nd Report of the Ethics Advisory Board

This Deliverable D4.9 provides the second report of AIDAVA’s Ethics Advisory Board of Independent Experts (EAB). It summarises the main activities of the EAB and provides details of current and next steps in ethics oversight of AIDAVA throughout 2024 and 2025.Throughout 2024 and 2025 the EAB had provided advisory on the implementation of G1 and planning for G2. For G1 the EAB attended an in person Workshop in Maastricht with Patient Consultants to prepare for evaluations throughout Summer 2024. The EAB also provided input on the results presented in the G1 Report.For G2 the EAB liaised closely with the Patient Advisory Board and Sustainability Board, providing input to the Consent Forms, Study Information Packages as well as amendments to the ethics approvals for G1 to support Developer Access to raw data for their implementation and validation work.The EAB advice remains focused on ensuring that the participant’s voice is heard clearly and that due consideration is given to their experience and feedback in participating in AIDAVA. They have explored other areas of relevance, including the role of synthetic data in testing and validation and with a wider view of the implications of newer regulations (including the AI Act and EHDS) on AIDAVA.As the project approaches the last year of its operation the EAB will focus on ethics issues associated with the execution of G2 and future plans for AIDAVA, particularly on the patient experience and user-friendliness of the App. They will continue to work closely with the Patient and Sustainability Advisory Boards. The EAB will continue to balance the advisory scope of their intervention role with the unique and hands-on approach they have taken in engaging with the project, its development and regulatory teams, fellow Advisory Boards and the Patient Consultants.