The objective is to ensure compliance with the ethics requirements set out in this work package.
Ethics requirements and potential ethical issues that may arise during this project are related to personal data, non-EU countries, and artificial intelligence.
Personal Data Protection:
Throughout the project, collection of any and all personal data through interviews for commercial purposes, workshops, and conferences will be in full adherence with Article 15 of the Grant Agreement (Personal Data Protection).
Implementation of EU standards:
Since this project involves partners from non-EU countries, we will ensure that modified biomaterial/devices manufactured in EU countries will not be exported to non-EU countries and/or imported back to the EU. Partnering institutions that handle biological material and will manufacture our biohybrid catheter are located in Spain and Italy, whose regulatory agencies recognize Quality-by-Design as a guiding evaluation principle; therefore, we do not foresee any ethical issues to be raised in this domain.
Artificial Intelligence we will use in the project should not raise any ethical concerns related to human rights and values because it will be used to train neural networks based on physico-chemical data and cannot be extended to other domains.
We do not foresee any harmful impact of BioMeld’s activities on the environment, stigmatization of particular social groups, misuse, or political or financial consequences.
The external independent Ethics Advisor for the project is Antonia Bierwith, who will be consulted on any potential issues regarding data protection and implementation of EU standards in non-EU countries.