D1.8 Legal and Ethical Considerations 1

This document is the outcome of the activities carried out within Task 1.4 'Legal and Ethical Framework' and it is the first of a series of reports, namely D1.8, D1.9 and D1.10, entitled 'legal and ethical considerations', which will be updated at month 6, 12 and 24, respectively. The purpose of this deliverable is to provide the legal and ethical framework of reference for the HEARTEN activities and the documents need for ethical approval of the activities carried out in WP 4. WP4 activities are devoted to the research of biomarkers identification, detection and measurements in breathing and in saliva of HF patients in order to define and start the activities on biosensors for the mHealth platform. Within the HEARTEN project only adult patients will be involved in the research activities. Patients will be recruited among HF patients. However, neither will be subjects vulnerable individuals, nor people unable to give consent; the studies will not include physical intervention on patients, but only sample collection by means of non invasive techniques (i.e. saliva and breath samples). Moreover, blood samples will be used for comparisons analysis from the same patients, but only as part of their routine schedule exams during hospitalization and within their follow up. Although the experimental study scheduled in the HEARTEN project do not include relevant dangers or risks for the participants, the HEARTEN project will take all required measures to protect also the physical and psychological safety of the patients that will be involved in the research studies. As to data protection, the research activities will involve the collection and processing of personal data. However, the sensitive data collected and processed will be limited to the patients' medical history, diagnoses, and medications.