Ethical submission

The description of the pilot and of preliminary functional evaluation in T8.1 were submitted for approval to the competent Ethical Committee. The Ethical Advisory Board (EAB) of MoveCare elaborated a consent form for participants that contains the following fundamental components: it describes all the information concerning the characteristics of the intervention, including the possible expected risks; it protects data confidentiality; it guarantees subjects freedom to refuse to participate to or to withdraw from the study at any time without affecting them in any way. The consent to participate is sought from the elder, but also from other possible users involved in the intervention (e.g. family/nonfamily caregivers). Particular attention will be paid on voice analysis. Although voice will be analyzed on-the-fly, that is it will never be stored or transmitted, some phone conversations are still required to tune the algorithms for voice analysis for transparent cognitive monitoring. On this issue, a specific and clear informed consent is provided to the elders, who will be able to filter and authorize the use of only part or none of the registered conversations, so that private content will not be violated. A specific procedure to ask such authorization is defined here. Only upon authorization phone conversation data can be used for research purpose. No other use will be allowed. Approval for early functional testing in T9.1 has to be obtained by M12. A plan (including insurance cover) for emergency situations that might occur during the pilot is designed in collaboration with the EAB. The National Ethical regulation (Italian and Spanish) for testing not certified devices must be followed and specific documentation is prepared for submission. To accomplish this task, the implementation of the different modules should be almost completed because all of the investigation brochures, manual of use should be ready together with a detailed risk analysis. Thus the ethical documentation for the overall pilot testing will be submitted in M24 in order to obtain the required approval before the pilot starting date in M27