Information Governance of Use of Health-Related Data in Medical Research in Scotland: Towards a Good Governance Framework

Abstract

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.

Keywords: information governance, proportionate governance, personal data, good governance framework, patient identifiable information, secondary uses of data, health-related research, SHIP, health informatics, regulatory landscape