Work Package 6 (WP6)

     The objective is to ensure compliance with the ‘ethics requirements’ during project implementation. The specific objective addressed by the project corresponds to the Coordination and Support Actions (CSA) and is aimed at establishment of knowledge exchange ties. As such, these actions do not involve ethical issues that have to be addressed during the direct implementation of proposed project. Nevertheless the training procedures may involve biobank collections of human samples and clinical information.

     In the present project previously collected biospecimens and data will be used as resource provided by LGDB (secondary use), no extra sampling of biospecimens is planned, although the project might initiate the development of novel clinical studies or clinical trials. Before the analysis of biospecimens and associated omics or clinical data preserved in LGDB, a project-specific approval from the Central Committee of Medical Ethics will be received according to internal LGDB and national regulations. Further transfer of clinical data abroad will be conducted only by permission of Central Committee of Medical Ethics and applied only for those individuals who have accepted the transmission of biospecimens and data abroad with a respective record in the signed informed consent submitted at the time of enrollment in LGDB. If needed, additional data from other biobanks associated with project partner institutions will be requested following their standard procedures and according to the legislation.