Journal article
The Governance Structure for Data Access in the DIRECT Consortium: An Innovative Medicines Initiative (IMI) Project
Harriet JA Teare, Federico de Masi, Karina Banasik, Anna Barnett, Sanna Herrgard, Bernd Jablonka, Jacqueline WM Postma, Timothy J McDonald, Ian Forgie, Piotr J Chmura, Emil K Rydzka, Ramneek Gupta, Soren Brunak, Ewan Pearson, Jane Kaye
Life Sciences, Society and Policy | Springer | Published : 2018
Abstract
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.
Grants
Awarded by Innovative Medicines Initiative Joint Undertaking from the European Union's Seventh Framework Programme (FP7/2007-2013)
Awarded by Novo Nordisk Foundation
Funding Acknowledgements
The work leading to this publication has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no 115317 (DIRECT), resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies' in-kind contribution. This work was also supported by the Novo Nordisk Foundation (grant NNF14CC0001 and NNF17OC0027594).