Responsible regulation in action? Responsible research and innovation and the European Bank for induced pluripotent stem cells

Abstract

ABSTRACTAmbitions for regenerative medicine remain a strong motivator for healthcare research and resource development. Central to the evolving vision for regenerative medicine are stem cells, and now human induced pluripotent stem cells (iPSCs). Against the promissory and technically innovative backdrop of this technology, there has been a growing concern for legitimacy and integrity in science and innovation. This, in turn, has encouraged discourses around the idea of ‘responsibility’, and the notion of ‘responsible research and innovation’ (RRI), which has gained considerable policy traction in Europe. This paper considers the concept of RRI within the context of a specific European research project: the European Bank for induced pluripotent Stem Cells (EBiSC). EBiSC is a resource development project – a biobank – that has as its stated aims the establishment of a leading European-based bank that will, inter alia, promote wider use of iPSCs and global iPSC banking with the ultimate aim of enhancing the health of people. Specifically, this paper considers how EBiSC’s Phase I (2014–2016) governance activities comply with expectations that might be distilled from RRI, and what RRI might impose on EBiSC’s post-Phase II (2017–2019) entity. In doing so, it offers some guidance on how RRI might be operationalised at the project level.