Report on Ethical and Competent Authorities approvals to conduct Clinical Investigation

Report on Ethical and Competent Authorities approvals to conduct Clinical InvestigationThis report wll include the material submitted to the Ethical Committee at UCD and to the Competent Authorities including the PIL and the Informed Consent FormThe PIL will include the following information The nature scope and purpose of the PORSAV studyThe data to be collected concerning the patient The rights of the patient under GDPR and otherwise to have their data deleted andor not distributedThe pseudonymisation of the data and the protection of patient privacy The possibility that the data may be used for future research work beyond the scope of the PORSAV studyThe Informed Consent Form will includeClarity that patient consent includes the use of the data for research and dissemination purposes and the eventual distribution recipients and use of the data Patients will be asked to consent to their pseudonymised data including images and video being used for research for dissemination and for training including for commercial purposes The consent form will be submitted to the patient for review and approval after the patient has read the PIL and had the opportunity to discuss it with hisher surgeon with the project team and with anyone else that heshe choosesContact information for the Data Protection Officer at UCD or IRCAD respectively The PIL and Informed Consent Form will be provided in English and French and will be written in simple clear language that is fully understandable by the patientThis deliverable includes examples of the PIL and the Informed Consent Form in both English and FrenchDeliverable D31 will include information on how the data minimisation principle is adhered to Deliverable D31 will describe the technical and organisational measures implemented to safeguard the rights and freedoms of the data subjectsresearch participants These will include a description of e the pseudonymisation techniques implemented