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CORBEL Report on ELSI support needs for BMS RIs and towards a joint Ethical Governance Framework

Cambon-Thomsen, Anne; Mayrhofer, Michaela Th.; Chassang, Gauthier; Schluender, Irene; Suhr, Stephanie

  1. The aim of the deliverable is to ultimately provide CORBEL partners with an Ethical Governance Framework (Annex 2) and Ethics Check procedure (Annex 3) building on the work of the Common Service ELSI of BBMRI-ERIC and the BioMedBridges project. It shall enable the partners to operate within agreed terms with respect to participant consent, ethics committee approvals and national regulations ensuring researchers supply and access data and/or samples whilst working under a common ethical framework. It aims to build a joint policy to address ELSI considerations of biological resource providers as well as to enhance related procedures for the user community of BMS RIs. Ethics requirements 2 (informed consent), 3 (incidental finding policy), 9 (procedures on data collection, etc) and 10 (relevant authorisations) are addressed in the general provisions of the CORBEL Ethical Governance Framework. CORBEL has to monitor the compliance of the Ethical Governance Framework (e.g. statement of adherence). The responsibility to meet these ethics requirements and legal compliance ultimately lies with the individual sample and/or data provider and not with the respective research infrastructures.

    Prior to implementation, the Ethical Governance Framework (including its templates) require validation of its processes and finally the approval of the Executive Board.
    The ultimate aim of this Work Package is to establish a single and sustainable support mechanism (Common Service) for all BMS RIs dealing with samples and/or data with ethical, legal and societal implications (ELSI). The submission of this report (D7.1) is an important achievement for reaching this goal.

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