Balancing the Local and the Universal in Maintaining Ethical Access to a Genomics Biobank
Date
22/11/2017Author
Heeney, Catherine
Kerr, Shona
Metadata
Abstract
Background: In policy and governance discussions of genetic and genomic data sharing, the rights of research subjects are often balanced against the scientific benefits of allowing open access to biomedical data. However, this dichotomous focus can obscure other matters that are relevant to the ethical running of the biobank. These include the will and the ability to sustain the resource. We will consider Generation Scotland (GS) as one context in which a global policy agenda favouring open access meets local issues of governance and sustainability. We seek to address gaps in discussion in scientific, law and policy arenas about the means to ensure that open access functions well but often neglects the contextual aspects of Biobanking. In order to explore these aspects we use the case of access to Generation Scotland. Participant recruitment and collection of data from the 24,000 plus participants in this genomics research biobank began in 2006 and a GS infrastructure continues to exist and manage access to a repository more than a decade later. We explore the balancing of data accessibility with ethical considerations and governance for GS in the evolving policy landscape of the past ten years. A time when data sharing and open data access have become increasingly important topics within the biomedical research community.
Methods: We carried out a review of policy documents and academic articles drawn from science and bioethics literatures. We focussed on literature covering open access, the protection of data subjects and questions pertaining to sustainability, for example in relation to funding or attribution of credit to repository staff. A further aspect of the methodology is based upon participant-observation within the Generation Scotland Access Committee, of which both authors are members.
Results: Using our engagement with GS we foreground the local elements of biorepository governance. Whilst decisions around data access are influenced by global policy objectives, local arrangements for governance and practices such as linkage to health records are also central. At the local level, we argue, moreover, that governance decisions regarding access to the biobank are intertwined with considerations about maintenance and viability. We show that in addition to the focus upon ever more universal and standardised practices, the local expertise and commitment built up when creating and maintaining repositories such as GS must be taken into account.
Conclusions: A commitment to open access in genomics research has found broad backing in science and health policy circles. This has led to a focus in science policy literature on facilitating access, at the risk of overlooking the contextual aspects of biobanking. Yet repositories of data and samples from human subjects may have to operate under managed access, to ensure both that the terms of consent are met and that the resource can be managed in a sustainable way. The importance of nurturing what is particular about the biobank in its local context, therefore, ought not to be ignored.
A video of this presentation can be viewed at https://media.ed.ac.uk/media/0_bw9i5gmn