ThrombUS+ D10.2: OEI - Requirement No. 2

According to the opinions of the ethics experts that evaluated the submitted proposal prior to its funding, the proposal raised several ethics issues. Among others, that the clinical trial C1 requires a continuous DVT monitoring of high-risk patients (postoperative and mostly bedridden), using the ThrombUS+ wearable device, from 12 hours after surgery and for 3 days. This raised questions about the vulnerability of the participants and their autonomy, especially because the applicants missed to indicate participation of vulnerable individuals in Part A Ethics Issues Table. Furthermore, partner PBY was presented as “social sciences expert involved in health technology deployments” to advise on the clinical studies/trials protocols (Section 2 - Preparedness status - in 3 clinical studies and 2 clinical trials descriptions); however, this is a research and consulting firm specialising in data and behavioural science to advise organisations on decision-making processes. Its expertise is not particularly relevant to address issues of autonomy and vulnerability in patients participating in clinical trials.Due to the abovementioned, it was indicated that the project must appoint an Ethics Advisor with expertise in human-centred technology (AI-powered technology in particular), to help prioritise the well-being of the participants in the clinical trials and studies, to help the project adopt an ethics-by-design approach (rather than a conformity-by-design technical approach) for the development of ThrombUS – ThrombUS+. A report by the ethics advisor must be submitted to cover these issues every year starting at M12.D10.2 is the publishable summary of the first yearly report compiled by the Independent Ethics Advisor appointed by the Consortium.