EGA (“the European Genome-phenome Archive”) serves as a repository for storing genomic and/or genetic data.
EGA is a source of permanent and secure archiving and exchange of all types of potentially identifiable genetic and phenotypic data resulting from biomedical research projects. The goal is to provide access to data, encourage data reuse, enable reproducibility, and accelerate biomedical and translational research.
To submit data to EGA, researchers must adhere to the guidelines outlined in EGA's documents. For example, EGA accepts 'de-identified' (pseudonymized) data. More information can be found on the EGA website: https://ega-archive.org/
KU Leuven requires researchers to inform participants about the use of their genomic data for future research and to broadly share this data for secondary research purposes. Informed consent for participation in the research ('ICF') should preferably explicitly and at least implicitly allow the sharing of data via databases that operate with controlled access (meaning that the data will only be made available if certain conditions are met). The researcher is responsible for the content of the ICF. DAC (Data Access Committee) will review the relevant ICF for each application.
Application and evaluation procedure
The KU Leuven researcher submits an application to DAC by completing the application form ("Application Form for KU Leuven researcher who wants to submit data to EGA"):
DAC aims to make a decision within a reasonable period. In the case of a positive decision, DAC will communicate this to the researcher, also requesting:
- If there is a PRET dossier (PRivacy en EThiek) and it has not yet been mentioned that the data will be deposited in EGA, to initiate a PRET amendment to indicate that data will be deposited in EGA (for more information: https://www.groupware.kuleuven.be/sites/pret/Pages/help.aspx?#Amendment)
- Submit the "submission request" to EGA
- In the submission request, only refer to dac@uzleuven.be
- Sign the EGA Data Processing Agreement (DPA) template, which the researcher receives from EGA after submitting the submission request, for acknowledgment (internal confirmation of their commitment).
- Provide the signed DPA to the supporting service, which will arrange for co-signing by legally authorized persons for KU Leuven/UZ Leuven.