Research Case Study: Good Governance for the Scottish Health Informatics Programme (SHIP)
Professor Graeme Laurie’s work tackles the myths and rhetoric of consent as well as the challenge of reducing regulatory burden when using health-related data. It confronts the paradigm of ‘consent or anonymise’ which has been applied to research on patient data and tissue, demonstrating that this approach is neither necessary nor sufficient in a robust governance framework that promotes responsible data linkage under a well-defined public interest mandate.
Linking health and health-related data is essential to understanding disease processes, drug development and monitoring, and health improvement. The legal basis for storing and linking health information has, however, been a matter of considerable dispute particularly in the absence of explicit consent from patients. England and Wales have pursued a legislative route to allow data linkages, but the same is not true in Scotland. The concern among the research community in Scotland has been a lack of clarity about the role of consent and the increasing regulatory burden in linkage and access procedures.
The Scottish Health Informatics Programme (SHIP) is a consortium effort between NHS Scotland, Scottish medical schools, and Edinburgh Law School which was charged with delivering a Good Governance Framework (GGF) to ensure valuable data are linked effectively and in the public interest while making sure that patient privacy is protected throughout. SHIP’s world-leading and state-of-the-art infrastructure facilitates the use of health-related records in medical research through an interdisciplinary collaboration involving the Universities of Dundee, Edinburgh, Glasgow and St Andrews, NHS Scotland and National Records Scotland. It was successfully launched in 2012.
The implementation of the SHIP GGF delivers faster, more transparent and consistent access to health researchers, within and beyond the NHS. The research also identified an unmet need for training on the legal, ethical and governance issues related to data sharing in medical research. This resulted in the design and delivery of an online training module which accredits researchers to use SHIP.
- Data Linkage Framework: Privacy Advisory Committee (Scottish Government)
- Guiding Principles for Data Linkage: Joined Up Data for Better Decisions (Scottish Government)
- National PAC for NHS Scotland Consultation Document
- The Collection, Linking and Use of Data in Biomedical Research and Health Care: Ethical Issues (Nuffield Council on Bioethics)
- Charter for Safe Havens in Scotland: Handling Unconsented Data from National Health Service Patient Records to Support Research and Statistics (Nov. 2015)