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In recent years, there has been a rise in the creation of DNA databases promising a range of health benefits to individuals and populations. This development has been accompanied by an interest in, and concern for the ethical, legal and social aspects of such collections. In terms of policy solutions, much of the focus of these debates has been on issues of consent, confidentiality and research governance. However, there are broader concerns, such as those associated with commercialisation, which cannot be adequately addressed by these foci. In this article, we focus on the health-wealth benefits that DNA databases promise by considering the views of 10 focus groups on Generation Scotland, Scotland's first national genetic database. As in previous studies, our qualitative research on public/s and stakeholders' views of DNA databases show the prospect of utilising donated samples and information derived for wealth-related ends (i.e. for private profit), irrespective of whether there is an associated health-related benefit, arouses considerable reaction. While health-wealth benefits are not mutually exclusive ideals, the tendency has been to cast 'public' benefits as exclusively health-related, while 'private' commercial benefits for funders and/or researchers are held out as a necessary pay-off. We argue for a less polarised approach that reconsiders what is meant by 'public benefits' and questions the exclusivity of commercial interests. We believe accommodation can be achieved via the mobilisation of a grass roots solution known as 'benefit-sharing' or a 'profit pay-off'. We propose a sociologically informed model that has a pragmatic, legal framework, which responds seriously to public concerns.

This initial scoping report outlines the original research to be undertaken for the legal work package of the Economic and Social Research Council (ESRC) funded Administrative Data Research Centre-Scotland (ADRC-S), by Professor Graeme Laurie and Ms Leslie Stevens based at the University of Edinburgh, School of Law and J Kenyon Mason Institute for Medicine, Life Sciences and the Law. The report provides an overview of the regulatory context in which administrative data linkages currently operate in Scotland, highlighting the crucial legal and ethical issues which arise from the current mixed legal landscape under which administrative data linkages operate. Adopting an approach that takes into account both the risks and the benefits that can be achieved through administrative data linkage research in the public interest, Laurie and Stevens argue for a principles-based approach to the governance of administrative data used for research purposes. By looking to established best practice in the field of data linkages in the health sector, and most notably the Good Governance Framework developed for the Scottish Health Informatics Programme (SHIP), the paper argues for a approach that will determine which principles can operate in a framework of robust and proportionate governance of administrative data linkages in Scotland. This is the first in a series of papers for the legal work package of the ESRC-funded ADRC-S. Subsequent papers will focus on particular research questions of the legal work package, notably the adaption of a principles based approach to the governance of administrative data; use of historical administrative data and the risks and benefits of commercial involvement in research.

This chapter addresses the considerable problems that arise within and between regulatory regimes when there is a failure to implement intelligent design that is responsive to the realities of life sciences research. We argue that a root cause of these problems is the dichotomization of regulatory regimes as between tissue and data and the creation of a non-nexus between bodies of knowledge and legal responses to technological developments. The result is a regulatory thicket and a net failure to deliver effective, efficient and proportionate regimes. Taking the UK and European context as its example, this chapter argues for a collapse in the distinction between tissue and data and for more fluid and reflexive governance systems that not only embody interdisciplinary intelligent design but are also constructed around legal architectures that are responsive to changing scientific and social mores. This requires less, not more, proscription from law.

This paper is the second in a series addressing information governance challenges in health-related research involving patient data and it is set against the current legislative and common law landscape within the UK. In Working Paper No.1 we described the diverse actors, regulatory bodies and systems in place within the current framework, and critically examined their roles relative to the different ethical and legal issues at stake and the surrounding literature. In light of this analysis, we advanced a template for good governance: a series of questions relating to benchmarks and standards against which existing and emerging governance models can be assessed. We then evaluated the current governance landscape against these standards, highlighting key areas that required improvement, concluding with recommendations for change. This paper moves one step further and examines more closely what it means to talk of good governance in the health-related research arena. We draw upon our research as part of the SHIP initiative – a consortium working to build the Scottish Health Informatics Platform, funded by the Wellcome Trust and in partnership with NHS Scotland. We build on our academic findings and practical experience of working iteratively with key policy and practice stakeholders in the field to propose a new model of good governance in practice. In particular, we consider how guiding principles and best practice, in tandem with a good governance template, provide not only a good governance framework for SHIP but also an approach that is transformative of the ways in which health-related research is carried out and governed, both in Scotland and elsewhere. The elements of good governance that we advance are set in the context of health data for research. It is important to note, however, that the lessons that can be learned from our work – and the model that we proffer - are applicable to a much broader range of governance settings, such as local authority and other public/private instances of data sharing. Our model adopts an approach of proportionate governance and is unique in this regard. It goes far beyond existing approaches to information governance in the research context while fully respecting relevant ethical and legal norms.