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Protecting and promoting public interest in the regulation of human health research

Research on the public benefits of health research regulation by the Mason Institute has resulted in multiple changes to practice in regulatory environments, both nationally and internationally.

3D model of DNA

The Mason Institute’s work has been underpinned by a series of research projects on (1) improving the regulation of human health research and (2) exploring the role of public interest in justifying robust health research in ways that are acceptable to the general public. This work has led to improved governance mechanisms for research on personal data across health and non-health sectors and the promotion of responsible research use of human biomedical collections in the UK and Europe. It has also influenced UK law reform to better capture the role of public interest in research regulation.

Responsible data use

The Good Governance Framework for data sharing in Scotland, which was developed by Professor Graeme Laurie and Dr Nayha Sethi and published in 2012, has since been endorsed and applied internationally within the health sector and beyond. It has been used as an important resource for a number of significant policy initiatives by the Canadian Institute of Health Research, including its health research data framework and Canada’s Tri-Agency Statement on Principles on Digital Management. The framework has also informed best practice in Ireland, with the Irish Health Board citing it at several points in their ‘Proposals for an Enabling Data Environment for Health and Related Research in Ireland’ to highlight that a principled, proportionate, risk-based approach to governance – as advocated by the Good Governance Framework - is required to support safe national research infrastructures. Further work with the Global Alliance for Genomics and Health by Professor Laurie and Dr Edward Dove led directly to the development and implementation of a Data Privacy and Security Policy across nearly 600 health research organisations in more than 50 countries.

Biomedical collections

Professor Laurie was, with colleagues Kathryn Hunter and Prof Sarah Cunningham-Burley, commissioned by Scottish Government from 2009 to 2013 to undertake a review of the Scottish Guthrie card collection and to make recommendations about its effective governance and future uses. The report and subsequent supporting materials, deliberations and conclusions from a ScotGov workshop in 2019 underpin the Scottish Government’s current approach to the Archive. They are also being used to shape and provide important supporting evidence for public consultation and engagement documentation being prepared to explore the use of the Archive as a unique research resource. In Europe, the report and Prof Laurie’s advice fed directly into a revised Council of Europe Recommendation on biomedical collections.

Public interest in law reform

When initially proposed, the UK’s Data Protection Act 2018 included a narrow reading of public interest that threatened to impede data sharing to the detriment of responsible health research. Research and advice by Annie Sorbie contributed directly to Wellcome’s parliamentary lobbying, who were successful in getting the Government to table an amendment to protect interventional research that was critically important for protecting clinical trials.