title: StemBANCC: Governing Access to Material and Data in a Large Stem Cell Research Consortium.
abstract: This paper makes the case for implementing an internal governance framework for sharing materials and data in stem cell research consortia. A governance framework can facilitate a transparent and accountable system while building trust among partner institutions. However, avoiding excessive bureaucracy is essential. The development and implementation of a governance framework for materials and data access in the Stem cells for Biological Assays of Novel drugs and prediCtive toxiCology (StemBANCC) consortium is presented as a practical example. The StemBANCC project is a multi-partner European research consortium, which aims to build a resource of 1,500 well characterised induced pluripotent stem cell (iPSC) lines for in vitro disease modelling and toxicology studies. The project governance framework was developed in two stages. A small working group identified key components of a framework and translated the project legal agreements into a draft policy document. The second phase allowed input from all consortium partners to shape the iterative development of a final policy document that could be agreed by all parties. Careful time management strategies were needed to manage the duration of this component. This part of the process also served as an exploratory space where different options could be proposed, potential gaps in planning identified, and project co-ordination activities specified.
authors.affiliation: HeLEX - Centre for Health, Law and Emerging Technologies, Department of Public Health, University of Oxford, Old Road Campus, Oxford, OX3 7LF, UK, michael.morrison@dph.ox.ac.uk.
authors.forename: Michael
authors.initials: M
authors.lastname: Morrison
authors.forename: Christine
authors.initials: C
authors.lastname: Klein
authors.forename: Nicole
authors.initials: N
authors.lastname: Clemann
authors.forename: David A
authors.initials: DA
authors.lastname: Collier
authors.forename: John
authors.initials: J
authors.lastname: Hardy
authors.forename: Barbara
authors.initials: B
authors.lastname: Heisserer
authors.forename: M Zameel
authors.initials: MZ
authors.lastname: Cader
authors.forename: Martin
authors.initials: M
authors.lastname: Graf
authors.forename: Jane
authors.initials: J
authors.lastname: Kaye
mesh_terms: D001681:Biological Assay / Q000592:standards*; D016208:Databases, Factual / Q000331:legislation & jurisprudence*; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards*; D057766:Policy; D057905:Stem Cell Research / Q000331:legislation & jurisprudence*
chemical_list: D004364:Pharmaceutical Preparations