Deliverable 2.20: RUMC clinical studies documentation

This deliverable provides comprehensive documentation on the regulatory, ethical, and legal approvals required for the clinical studies conducted by RUMC 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 associated with the clinical Use Cases led by RUMC under the HEREDITARY project. Data from four previous studies will be included in the HEREDITARY project that obtained previous authority from the regulating ethical authority depending on the Wet Medisch-Wetenschappelijk Onderzoek (WMO1). RUMC is committed to the FAIR principles of data management. We strive to adhere to those whenever possible. 

interactions at mucosal sites and distant sites such as brain diseases. Linking multiple modalities will help to understand the complex relationship between pathology, the microbiome and the brain creating new insights in biology. In addition, the linkage of the data in these Use Cases within HEREDITARY serves as an example for federated learning. For all RUMC datasets in question, there is a minimal risk of incidental findings by the analyses we will perform. Although the risk for incidental findings is low, due to the type of analysis performed, 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 RUMC Use Cases 4 and 5 of linking gut and brain and extracting clinical value from this linkage. 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.