Genetic and other types of medical data are a central resource for biomedical research today. Through integration of large data sets, novel approaches for identifying clinically relevant genetic variants as well as new correlations and patterns that could affect treatment can be discovered. Key to success of this endeavour is a robust and safe infrastructure for large-scale collection, analysis and sharing of genetic and other medical data.
The German Human Genome-Phenome Archive (GHGA) aims to develop a central database for medical data, which allows the collection and long-term storage of data for secondary use in biomedical research. On an international level, the GHGA will function as a federated node of the European Genome-Phenome Archive (EGA) thus allowing German researchers to help shape future international standards for data exchange and governance and to take on leading roles in international research consortia. This is an interdisciplinary project which brings together scientists and specialists from various fields including software developers, cloud computing specialists, bioinformaticians, medical professionals, and ELSI researchers. (For further information, see: https://www.ghga.de/.)
Besides the technical side of the project which aims to build the actual storage infrastructure and data-related services, we are collaborating closely with legal scholars to identity, anticipate and address issues concerning the ethics of consent, data sharing and data governance. Our main objectives are to:
- Determine the needs and interests of patients (and research subjects) concerning the secondary use of their data
- Investigate the possibilities for patient engagement and participation in GHGA, and explore options to involve them actively and sustainably in the governance of the archive in order to establish a culture of trust and exchange of perspectives
- Develop informed consent solutions for GHGA that allow data to be collected and used for medical research
- Identify ethical principles for data use and access and work towards a normative framework for decisions by Data Access Committees
- Develop an international data governance framework for GHGA