Deliverable 2.19: UNITO clinical studies documentation

This deliverable provides comprehensive documentation on the regulatory, ethical, and legal approvals required for the clinical studies conducted by UNITO as part of the HEREDITARY project. It details the procedures followed to secure the necessary approvals, ensuring full compliance with relevant regulatory bodies, ethical standards, and data protection laws.

The document covers ethical approvals, regulatory compliance, and data access and transfer agreements associated with the clinical use cases led by UNITO under the HEREDITARY project. It also outlines the processes for obtaining informed consent for new data collection, ensuring that consent is freely given, specific, informed, and unambiguous. The enrolment procedures at UNITO are meticulously designed to meet these requirements.

Additionally, the deliverable addresses the potential for incidental findings during research. The HEREDITARY project has established an incidental findings policy that respects the privacy rights of participants while considering ethical obligations. Although the use of anonymized data minimizes the risk of linking incidental findings to individual participants, the policy provides clear guidelines on how to manage such findings if they occur.

Overall, this deliverable demonstrates HEREDITARY's commitment to ethical research practices and the protection of data subjects in the design of Use Cases 1 and 2. By aligning with GDPR, upholding rigorous ethical standards, and implementing comprehensive data protection measures, the project ensures that its research contributes to scientific knowledge while respecting the privacy and autonomy of participants.