KU Leuven requires researchers to inform participants about the use of their genomic data for future research and to share it broadly for secondary research purposes (dissemination of this data for secondary research). Informed consent for participation in the research ("ICF") preferably should explicitly and at least implicitly allow data sharing through databases that operate with controlled access (meaning that the data will only be made available if certain conditions are met) and with other academic institutions.
EGA ("the European Genome-phenome Archive") can be used as a repository for storing genomic and/or genetic data.
Access to datasets by third parties must be approved by the DAC.
Application and evaluation procedure
The external applicant wishing to access a dataset from a KU Leuven researcher submits an application to the DAC by filing the application form ("Application Form for Access to the KU Leuven researchers’ Data (Third party researchers)").
The DAC Desk will inform the KU Leuven researcher and request their approval for this specific application. The researcher will also be informed that a PRET amendment must be initiated to indicate that the data will be transmitted if a PRET file exists, and it has not been indicated therein that the data will be transmitted (for more information: https://www.groupware.kuleuven.be/sites/pret/Pages/help.aspx?#Amendment).
The KU Leuven researcher must provide the following information to the DAC:
If it is an EGA dataset:
- Who submitted the dataset to EGA (the principal investigator, VIB researcher, etc.);
- Whether existing agreements (e.g., MTA) apply to the dataset and who (CTC/LRD) handled them;
- Confirmation that a PRET amendment file for depositing the data in EGA is in order.
If it is not an EGA dataset:
- Whether existing agreements (e.g., MTA) apply to the dataset and who (CTC/LRD) handled them.
DAC aims to make a decision within a reasonable timeframe.
Data can only be shared after DAC approval and after the preparation and valid signing of a Data Transfer Agreement as negotiated between the relevant legal department of UZ/KU Leuven and the external applicant.