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

Life Sci Soc Policy. 2018 Sep 4;14(1):20. doi: 10.1186/s40504-018-0083-0.

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.

Keywords: Data access; Data access committee; Governance; IMI project.

MeSH terms

  • Access to Information*
  • Biomedical Research*
  • Clinical Governance*
  • Databases, Factual*
  • Humans
  • Public-Private Sector Partnerships*