GDI D2.9 Evaluation of data governance experiences - Report

The 1+MG Declaration foresees a harmonised data governance for the genomic data infrastructure, which is applicable to all data included into and used from the 1+MG data infrastructure. Data governance is a central element for the entire design of the 1+MG data infrastructure. It influences the legal implementation as well as the IT infrastructure and the information management, which must reflect and enable the workflows of the data governance. 

In WP2 of the GDI project, we are developing recommendations for such data governance with respect to the data access procedure for scientific research, healthcare reuse, policy development and quality management as well as governance for inclusion of data into 1+MG and for data use. We aim for an agreement between the national representatives on the governance panel on data governance which is pivotal to prepare the implementation. 

This deliverable reports on experience collected from existing national and international data infrastructures with the focus on data access governance. This is based on input gathered in the project HealthData @ EU and complemented by information gathered in a workshop that we organised ourselves. WP2 organised in September 2023 a workshop with representatives from various European data infrastructures for secondary use and 1+MG ELSI Working Group members. 

Before the workshop, participants were queried on practical aspects of data governance for secondary use, also beyond research purposes. The results of this survey allow us to conclude that all currently envisaged purposes for secondary use are relevant to generate value from genomic and health data. Among these purposes, scientific research and policy development purposes can build on a similar data governance on the one hand, and so can healthcare reuse and quality management purposes on the other hand. Budget needs to be foreseen will be needed to set up a Data Access Committee (DAC) with dedicated staff at the genomic data infrastructure, to develop IT tools supporting the data governance workflows as well as to generate and provide clear and harmonised information, materials and procedures to applicants. These upfront investments will allow us to reduce administrative costs later caused by incomplete applications and high needs for direct communications with applicants. Finally, we envisage in principle an open ended retention time for the data, subject to a regular assessment of future usability of the data, to allow the creation of more value from data. The value for future use has to be balanced with capacities, cost and future technical developments.