The governance structure for data access in the DIRECT consortium: an innovative medicines initiative (IMI) project.

Autor: Teare HJA; HeLEX Centre, University of Oxford, Ewert House, Banbury Road, Oxford, OX2 7DD, UK. harriet.teare@dph.ox.ac.uk.; Melbourne Law School, University of Melbourne, 185 Pelham Street, Carlton, VIC, 3053, Australia. harriet.teare@dph.ox.ac.uk., de Masi F; Center for Biological Sequence Analysis, Department of Bio and Health Informatics, Technical University of Denmark, Building 208, DK-2800, Lyngby, Denmark., Banasik K; Translational Disease Systems Biology, NNF Center for Protein Research, University of Copenhagen, Faculty of Health and Medical Sciences, Blegdamsvej 3B, DK-2200, Copenhagen, Denmark., Barnett A; Division of Molecular & Clinical Medicine, School of Medicine, University of Dundee, Ninewells Hospital & Medical School, Dundee, UK., Herrgard S; Center for Biological Sequence Analysis, Department of Bio and Health Informatics, Technical University of Denmark, Building 208, DK-2800, Lyngby, Denmark., Jablonka B; Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, 65926, Frankfurt, Germany., Postma JWM; Clinical Research Centre, Lund University Diabetes Centre, Box 50332, SE-202 13, Malmö, Sweden., McDonald TJ; Blood Sciences, Template A2, Royal Devon and Exeter Hospital, Barrack Road, Exeter, EX2 5DW, UK., Forgie I; Division of Molecular & Clinical Medicine, School of Medicine, University of Dundee, Ninewells Hospital & Medical School, Dundee, UK., Chmura PJ; Center for Biological Sequence Analysis, Department of Bio and Health Informatics, Technical University of Denmark, Building 208, DK-2800, Lyngby, Denmark., Rydzka EK; Center for Biological Sequence Analysis, Department of Bio and Health Informatics, Technical University of Denmark, Building 208, DK-2800, Lyngby, Denmark., Gupta R; Center for Biological Sequence Analysis, Department of Bio and Health Informatics, Technical University of Denmark, Building 208, DK-2800, Lyngby, Denmark., Brunak S; Center for Biological Sequence Analysis, Department of Bio and Health Informatics, Technical University of Denmark, Building 208, DK-2800, Lyngby, Denmark.; Translational Disease Systems Biology, NNF Center for Protein Research, University of Copenhagen, Faculty of Health and Medical Sciences, Blegdamsvej 3B, DK-2200, Copenhagen, Denmark., Pearson E; Division of Molecular & Clinical Medicine, School of Medicine, University of Dundee, Ninewells Hospital & Medical School, Dundee, UK., Kaye J; HeLEX Centre, University of Oxford, Ewert House, Banbury Road, Oxford, OX2 7DD, UK.; Melbourne Law School, University of Melbourne, 185 Pelham Street, Carlton, VIC, 3053, Australia.
Jazyk: angličtina
Zdroj: Life sciences, society and policy [Life Sci Soc Policy] 2018 Sep 04; Vol. 14 (1), pp. 20. Date of Electronic Publication: 2018 Sep 04.
DOI: 10.1186/s40504-018-0083-0
Abstrakt: Biomedical research projects involving multiple partners from public and private sectors require coherent internal governance mechanisms to engender good working relationships. The DIRECT project is an example of such a venture, funded by the Innovative Medicines Initiative Joint Undertaking (IMI JU). This paper describes the data access policy that was developed within DIRECT to support data access and sharing, via the establishment of a 3-tiered Data Access Committee. The process was intended to allow quick access to data, whilst enabling strong oversight of how data were being accessed and by whom, and any subsequent analyses, to contribute to the overall objectives of the consortium.
Databáze: MEDLINE
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