Graeme Laurie is Professor of Medical Jurisprudence at the University of Edinburgh and Founding Director of the JK Mason Institute for Medicine, Life Sciences and the Law. He is the holder of a Wellcome Trust Senior Investigator Award and Principal Investigator for a project entitled Confronting the Liminal Spaces of Health Research Regulation. This is a £1 million, five-year, interdisciplinary project running from October 2014 until September 2019. You can follow more details of the project here: @LiminalSpacesWT.
Graeme Laurie served as the Director of Research for the School of Law (2011-2014). He previously held the role of PI and Director of the Arts and Humanities Research Council (AHRC) Research Centre for Studies in Intellectual Property and Technology Law - also known as SCRIPT - from 2007-2011 until he took up the position of Director of Research.
Ph.D. supervision interests
Interested in all proposals relating to medical law and ethics, especially health research regulation, privacy, and legal responses to advances in genetics and genomics. Watch out for regular partial PhD scholarships via our McLagan Fund, administered by the Mason Institute (see above).
Current Research Interests
His research interests include the role of law in promoting and regulating science, medicine and technology. He has been involved in numerous successful collaborative bids with groups of law and non-law colleagues, including clinicians, geneticists and medical social scientists, to the total value of c.£15 million. These include: AHRC/SCRIPT Phase 1 c.£1 million (2002-2007); ESRC Innogen Phase 1 c.£1.9 million (2002-2007); Generation Scotland [SHEFC] c.£1.8 million (2003-2008); AHRC/SCRIPT Phase 2 c.£1.5 million (2007-2012); ESRC Innogen Phase 2 c.£2.5 million (2007-2014); Wellcome Trust Scottish Health Informatics Programme - SHIP consortium c.£3.6 million (2009-2014); and MRC/WT et al. Farr Institute, c.£4 million (2013-2018). The total sums directly attributable to Edinburgh Law School are in excess of £4 million. The focus of these collaborative efforts has always been legal and ethical dimensions of medical and scientific developments, with particular emphasis on the responsible promotion of medical science.
In addition to the Wellcome Trust Liminal Spaces Project, Graeme Laurie is currently involved in three other externally-funded initiatives:
- EU Commission's Innovative Medicines Initiative on stem cell banking: EBiSC (2014-2017)
- ESRC Administrative Data Research Centres: ADRC Scotland (2013-2018)
- 10-funder consortium on data linkage for health research: Farr Institute (2013-2018)
In policy terms, Graeme Laurie was the Chair of the permanent UK Biobank Ethics and Governance Council from 2006-2010 and Chair of the Privacy Advisory Committee in Scotland from 2005-2013. He served as the Founding President of the European Association of Health Law from 2008-2013. He has also held membership of a number of external professional and policy bodies including the Nuffield Council on Bioethics and the British Medical Association's Medical Ethics Committee, both from 2009-2015. He served as a member of the Royal Society Working Group on Science as an Open Enterprise (2011-12), and the Canadian Academies' Expert Panel on Timely Access to Health and Social Data for Health Research and Health System Innovation (2014-2015). He was the UK representative on the Council of Europe Expert Group on the revision of Recommendation 2006(4) on research on biological materials of human origin (2012-2016), which led to the adoption of a new Recommendation in May 2016.
Also in 2016, in June, Edinburgh hosted the 13th World Congress of the International Association of Bioethics. Graeme Laurie was the Chair of the UK Organising Committee, working with professional conference organiser, Conference Partners, and the host venue the Edinburgh International Conference Centre. The theme of the Congress was Individuals, Public Interests and Public Goods: What is the Contribution of Bioethics? The IAB2016 event had a particular focus on early career researchers and art+ethics. It attracted over 700 delegates from 44 countries and more details of the legacy can be found on the website here.
Graeme Laurie is co-editor of the Cambridge University Press monograph series on Bioethics and Law (with Richard Ashcroft, QMUL). He is also a member of the editorial teams of the European Journal of Health Law, Medical Law International, Law, Innovation & Technology, International Journal of Population Data Science, and the SCRIPT Centre's own online journal SCRIPT-ed.
Contemporary Issues in Medical Jurisprudence (LLM) (Course Organiser)
Fundamental Issues in Medical Jurisprudence (LLM) (Course Organiser)
Contemporary Issues in Medical Jurisprudence (Honours) (Course Organiser)
Fundamental Issues in Medical Jurisprudence (Honours) (Course Organiser)
Edward Dove 'Promoting Health Research and Protecting Participants? The Impact of 'Next-Generation' Health Research Regulation on Research Ethics Committees'
Laura Downey 'Technological Challenges to Legal Norms in Health Care'
Catriona McMillan ''The Human Embryo in vitro: A Processual Entity in Legal Stasis''
Maureen O'Sullivan 'Deconstructing Patents at the Edge of Reason'
Zoe Picton-Howell 'What Does the Law Bring to Difficult Medical Decision Making on Behalf of Children with Complex Health Problems and Disability?'
Emily Postan 'Defining Ourselves: self-construction and the governance of personal biological information'
Annie Sorbie 'Appeals to the public interest in health research regulation (HRR): are the public interested?'
Books and Reports
Graeme Laurie, Shawn Harmon, Gerard Porter, Mason and McCall Smith's Law and Medical Ethics, (Oxford University Press, 2016)
Abstract: This classic textbook has provided students of medical law and ethics with a framework for exploring this fascinating subject for over 30 years. Providing coverage of all of the topics found on medical law courses, it gives an overview of the inter-relationship between ethical medical practice and the law.Medical law is significantly shaped by the courts, and as such this book provides extensive coverage of recent judicial decisions as well as statutory developments. This book has continually evolved to reflect changes in the law and shifting ethical opinions and the tenth edition continues to fulfil this remit.
Graeme Laurie, Pamela Ferguson, Inspiring a Medico-Legal Revolution: Essays in Honour of Sheila McLean, (Ashgate Publishing, 2015)
Abstract: This book marks the retirement of Professor Sheila McLean, whose contribution to the discipline of medical law has been truly ground breaking. As one of the pioneers of the discipline, Sheila McLean inspired a revolution in the ways in which lawyers, doctors, courts and patients perceive the relationship between medicine and the law. The first International Bar Association Professor of Law and Ethics in Medicine, she has worked tirelessly to champion the importance of law’s role in regulating medicine and protecting patients’ rights. The span in content of this book reflects the range of contributions that Professor McLean has herself made. Her work gave direction and shape to a new field of study at a time when few questioned the authority of medicine or thought much about the plight of the patient. This collection brings together 21 leading scholars in healthcare law and ethics to honour the depth and significance of her contribution. Including authors from the US, Australia, Canada and New Zealand, the contributions cover areas as diverse as start and end of life, reproductive rights and termination of pregnancy, autonomy of patients, the protection of vulnerable patient groups, and the challenges posed by new technologies.
Andrew K. Byerring, Marni Brownell, Khaled El Emam, Isabel Fortier, David Henry, Bartha M. Knoppers, Graeme Laurie, Trudo Lemmens, Matthew Morgan, Thomas William Noseworthy, Stephen Saunders, Michael Wolfson, Jennifer Zelmer, Accessing Health and Health-Related Data in Canada: The Expert Panel on Timely Access to Health and Social Data for Health Research and Health System Innovation, (Council of Canadian Academies, 2015)
Abstract: Key FindingsFor effective research with health and health-related data, disparate sources of data must be brought together. Providing these data in an “analysis-ready” format, thereby allowing statistical relationships or patterns to be derived, is a central methodological challenge.Evidence shows that timely access to data enables significant high-quality research that can have far-reaching effects for health care and the overall health of Canadians.The risk of potential harm resulting from access to data is tangible but low. The level of risk can be further lowered through effective governance mechanisms.Timely access to data is hindered by variable legal structures and differing interpretations of the terms identifiable and de-identified across jurisdictions. Instead of rigidly classifying data as either identifiable or non-identifiable, it is useful to view de-identification as a continuum and to adjust access controls accordingly.Evidence demonstrates that a shift is occurring among leading entities from a 'data custodianship' model to a 'data stewardship' model. Central to the success of this shift is the adoption of good governance practices, specifically in privacy governance, research governance, information governance, and network governance.
Graeme Laurie, Leslie Stevens, Kerina H. Jones, Christine Dobbs, A Review of Evidence Relating to Harm Resulting from Uses of Health and Biomedical Data, (Nuffield Council on Bioethics, 2015)
Abstract: Prepared for the Nuffield Council on Bioethics Working Party on Biological and Health Data and the Expert Advisory Group on Data Access.
Graeme Laurie, Kathryn Hunter, Sarah Cunningham-Burley, Storage, Use and Access to the Scottish Guthrie Card Collection: Ethical, Legal, and Social Issues, (Scottish Government Social Research, 2014)
Abstract: This report considers the ethical, legal and social issues surrounding the existence, continued storage and future uses of the newborn screening collection held in Scotland (also known as the Guthrie card collection). The report was written over a four year period, 2009-2013, during which time earlier drafts of the report ensured that Guthrie Cards were included in the developing governance regime for biomedical collections within Scotland. This final version is an account of developments as of April 2013 and involves an evaluation of the current arrangements as far as this is possible in a fast-moving field. The report also serves as a platform for future dialogue and development in light of wider social and international changes that are occurring, most notably in terms of the growing role for empowered citizens to contribute to, and benefit from, the future direction of health-related research.
S. Davidson, C MCLEAN, Steven Treanor, Mhairi Aitken, Sarah Cunningham-Burley, Graeme Laurie, Claudia Pagliari, Nayha Sethi, Public Acceptability of Data Sharing Between the Public, Private and Third Sectors for Research Purposes, (Scottish Government, 2013)
Thomas Baldwin, Jonathan Cole, Maria Fitzgerald, Jenny Kitzinger, Graeme Laurie, Jack Price, Nikolas Rose, Steven Rose, Ilina Singh, Vincent Walsh, Kevin Warwick, Novel Neurotechnologies: Intervening in the Brain, (Nuffield Council on Bioethics, 2013)
Graeme Laurie, Charlotte Waelde, Abbe Brown, Smita Kheria, Jane Cornwell, Contemporary Intellectual Property: Law and Policy, (Oxford University Press, 2013)
Abstract: Contemporary Intellectual Property: Law and Policy offers a unique perspective on intellectual property law, unrivalled amongst IP textbooks available today. Beyond providing an up-to-date account of intellectual property law, the text examines the complex policies that inform and guide modern IP law at the domestic (including Scottish), European and international levels, giving the reader a true insight into the discipline and the shape of things to come. The focus is on contemporary challenges to intellectual property law and policy and the reader is encouraged to engage critically both with the text and the subject matter. Carefully developed to ensure that the complexities of the subject are addressed in a clear and approachable manner, the extensive use of practical examples, exercises and visual aids throughout the text enliven the subject and stimulate the reader. Online Resource Centre: Students and lecturers alike can access extensive updates to the key areas of law, as well as pointers on answering the discussion points posed in the text. Also included are two bonus chapters; 'History of Registered Design Law in the UK to 1988' and 'History of Unregistered Design Protection in the UK'.
Graeme Laurie, Ken Mason, Mason and McCall Smith's Law and Medical Ethics, (Oxford University Press, 2013)
Abstract: This classic textbook has provided students of medical law and ethics with a framework for exploring this fascinating subject for over 25 years. Providing coverage of all of the topics found on medical law courses, it gives an overview of the inter-relationship between ethical medical practice and the law. The authors, both hugely experienced and influential in the field, offer their own opinions on current debates and controversies, and thereby encourage readers to formulate their own views and arguments.As a still-developing discipline, medical law is significantly shaped by the courts, and as such this book provides extensive coverage of recent judicial decisions as well as statutory developments. This edition continues to take a comparative approach, with particular importance attached to the shift in influence from transatlantic jurisdictions to those of the EU.This book has continually evolved to reflect changes in the law and shifting ethical opinions - this ninth edition continues to fulfil this remit and is essential reading for any serious medical law student or practitioner, as well as being of interest to all those involved in the delivery and control of modern healthcare.Readership: This text is primarily for undergraduate students opting to take medical law modules, or postgraduates studying medical law and ethics. It is also sometimes used on nursing and medicine courses as supplementary reading.
Shawn Harmon, Fabiana Arzuaga, Graeme Laurie, Regenerative Medicine Regulation: Global Issues and Argentine Opportunities, (AHRC Research Centre for Studies in Intellectual Property and Technology Law, 2011)
Abstract: Policy Brief 1:2011 Drawing on a 2-day interactive expert workshop held on 7-8 November 2011 at the ESRC Genomics Forum in Edinburgh under the Forum’s Bright Ideas Programme, and also drawing on interdisciplinary engagements between interested stakeholders in the Argentine and UK regenerative medicine field that have been ongoing for some four years, this Policy Brief explores key issues in the regulation of cellular products, and, drawing on the EU and UK experience, makes a number of recommendations for regulation in Argentina.
Hector MacQueen, Charlotte Waelde, Graeme Laurie, Abbe Brown, Contemporary Intellectual Property: Law and Policy, (Oxford University Press, 2010)
Graeme Laurie, Ken Mason, End of Life Assistance (Scotland) Bill, (AHRC Research Centre for Studies in Intellectual Property and Technology Law, 2010)
Graeme Laurie, Ken Mason, Mason and McCall Smith's Law and Medical Ethics, (Oxford University Press, 2010)
Graeme Laurie, Shawn Harmon, Genomic Medicine: Response to House of Lords Science and Technology Committee, (AHRC Research Centre for Studies in Intellectual Property and Technology Law, 2008)
Shawn Harmon, Graeme Laurie, The Regulation of Human Tissue and Regenerative Medicine In Argentina: Making Experience Work, (AHRC Research Centre for Studies in Intellectual Property and Technology Law, 2008)
Shawn Harmon, Graeme Laurie, Fabiana Arzuaga, Regulation of Clinical Research Involving Stem Cells: Towards the Construction of a Regulatory Model for Argentina Learning from the Experiences of the United Kingdom, (SCRIPT, 2008)
Abstract: Report on a workshop organised by the University of Edinburgh and the Agency for the Promotion and Science & Technology, Buenos Aires, Argentina 29-30 November 2007 on a stem cell research governance scheme in Argentina.
Graeme Laurie, OECD Draft Guidelines on Biobanks, (AHRC Research Centre for Studies in Intellectual Property and Technology Law, 2008)
Graeme Laurie, Data Sharing: Response to the Ministry of Justice Consultation, (AHRC Research Centre for Studies in Intellectual Property and Technology Law, 2008)
Hector MacQueen, Graeme Laurie, Abbe Brown, Contemporary Intellectual Property: Law and Policy, (Oxford University Press, 2007)
Abstract: The book offers an original perspective on intellectual property law. Beyond providing a thorough and up-to-date account of intellectual property law, the text examines the complex policies that inform and guide modern IP law at the domestic (including Scottish), European and international levels. The focus is on contemporary challenges to intellectual property law and policy.
Graeme Laurie, Ken Mason, Mason and McCall Smith's Law and Medical Ethics, (Oxford University Press, 2006)
Abstract: This is the seventh edition of this medical law textbook, and continues to provide an overview of the inter-relationship between medical ethics and practice and the law. There is, therefore, an emphasis on those aspects of medical practice that are governed, to a large extent, by the moral law. However, medical law, as such, is still a developing discipline which is being mainly shaped by the courts and there is extensive coverage of seminal and recent judicial decisions, particular attention being given to those which define the limits of professional freedom in the light of the increasing importance attached to personal autonomy. The book incorporates a strong element of comparative medical law having a particular interest in the shift of influence from other Anglophone jurisdictions to those in Europe. The text is directed in the main to students and practitioners of law but the overarching importance attached to ethical principles broadens its appeal to all those involved in the control and delivery of modern healthcare.
Graeme Laurie, Johanna Gibson, Generation Scotland: Legal and Ethical Aspects, (AHRC Research Centre for Studies in Intellectual Property and Technology Law, 2005)
Graeme Laurie, Genetic Databases: Assessing the Benefits and Impact on Human and Patient Rights, (World Health Organisation Regional Office for Europe, 2003)
Graeme Laurie, Genetic Privacy: A Challenge to Medico-Legal Norms, (Cambridge University Press, 2002)
Abstract: The phenomenon of the New Genetics raises complex social problems, particularly those of privacy. This book offers ethical and legal perspectives on the questions of a right to know and not to know genetic information from the standpoint of individuals, their relatives, employers, insurers and the state. Graeme Laurie provides a unique definition of privacy, including a concept of property rights in the person, and argues for stronger legal protection of privacy in the shadow of developments in human genetics. He challenges the role and the limits of established principles in medical law and ethics, including respect for patient autonomy and confidentiality. This book will interest lawyers, philosophers and doctors concerned both with genetic information and issues of privacy; it will also interest genetic counsellors, researchers, and policy makers worldwide for its practical stance on dilemmas in modern genetic medicine.
Ken Mason, Graeme Laurie, Alexander McCall-Smith, Law and Medical Ethics, (Butterworths, 2002)
Abstract: This new edition of Law and Medical Ethics continues to chart the ever-widening field that the topics cover. The interplay between the health caring professions and the public during the period intervening since the last edition has, perhaps, been mainly dominated by wide-ranging changes in the administration of the National Health Service and of the professions themselves but these have been paralleled by important developments in medical jurisprudence.
M. J Taylor, Edward S. Dove, Graeme Laurie, D Townend, 'When can the child speak for herself? The limits of parental consent in data protection law ', (2017), Medical Law Review, pp 1-12
Abstract: Draft regulatory guidance suggests that if the processing of a child’s personal data begins with the consent of a parent, then there is a need to find and defend an enduring consent through the child’s growing capacity and on to their maturity. We consider the implications for health research of the UK Information Commissioner’s Office’s (ICO) suggestion that the relevant test for maturity is the Gillick test, originally developed in the context of medical treatment. Noting the significance of the welfare principle to this test, we examine the implications for the responsibilities of a parent to act as proxy for their child. We argue, contrary to draft ICO guidance, that a data controller might legitimately continue to rely upon parental consent as a legal basis for processing after a child is old enough to provide her own consent. Nevertheless, we conclude that data controllers should develop strategies to seek fresh consent from children as soon as practicable after the data controller has reason to believe they are mature enough to consent independently. Techniques for effective communication, recommended to address challenges associated with Big Data analytics, might have a role here in addressing the dynamic relationship between data subject and processing. Ultimately, we suggest that fair and lawful processing of a child’s data will be dependent upon data controllers taking seriously the truism that consent is ongoing, rather than a one-time event: the core associated responsibility is to continue to communicate with a data subject regarding the processing of personal data.
Graeme Laurie, Edward S. Dove, Isabel Fletcher, Agomoni Ganguli-Mitra, Catriona McMillan, Nayha Sethi, Annie Sorbie, 'Charting regulatory stewardship in health research: Making the invisible visible?', (2017), Cambridge quarterly of healthcare ethics
Abstract: This article analyses a hitherto largely obscured feature of regulatory environments in health research, namely, the role of regulatory stewardship. Through examples drawn from research ethics committees, emerging technologies, and governance of research resources, it outlines the essential features of regulatory stewardship, and argues that this concept can demonstrate considerable added value for all parties in delivering and benefiting from efficient and effective navigation of regulatory landscapes. It offers an exposition of the normative principles and associated responsibilities of the concept. The extant invisibility of regulatory stewardship requires fuller recognition and better integration of the approach into the effective functioning of law and regulation in the health research context.
Mary Dixon-Woods, David Kocman, Liz Brewster, Janet Willars, Graeme Laurie, Carolyn Tarrant, 'A qualitative study of participants’ views on re-consent in a longitudinal biobank ', (2017), BMC Medical Ethics, pp 1-11
Abstract: Biomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or “biobanks” over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank.Participants’ perceptions of research as a process of mutual co-operation between volunteer and researcher were fundamental to their views on consent. Consenting arrangements for biobanks should respect the cooperative values that are important to participants, recognise the two logics used by research volunteers, and avoid rigidity. Agility may be favoured by tiered consent combined with strong oversight mechanisms; this approach requires evaluation.
Agomoni Ganguli Mitra, Edward S. Dove, Graeme Laurie, Samuel Taylor-Alexander, 'Reconfiguring social value in health research through the lens of liminality ', (2017), Bioethics, pp 87-96
Abstract: Despite the growing importance of ‘social value’ as a central feature of research ethics, the term remains both conceptually vague and to a certain extent operationally rigid. And yet, perhaps because the rhetorical appeal of social value appears immediate and self-evident, the concept has not been put to rigorous investigation in terms of its definition, strength, function, and scope. In this article, we discuss how the anthropological concept of liminality can illuminate social value and differentiate and reconfigure its variegated approaches. Employing liminality as a heuristic encourages a reassessment of how we understand the mobilization of ‘social value’ in bioethics. We argue that social value as seen through the lens of liminality can provide greater clarity of its function and scope for health research. Building on calls to understand social value as a dynamic, rather than a static, concept, we emphasize the need to appraise social value iteratively throughout the entire research as something that transforms over multiple times and across multiple spaces occupied by a range of actors.
Graeme Laurie, Kerina Jones, Leslie Stevens, Christine Dobbs, Nathan Lea, David V Ford, 'The other side of the coin: Harm due to the non-use of health-related data', (2017), International journal of medical informatics, Vol 97, pp 43-51
Abstract: This article uses an international case study approach to explore why data non-use is difficult to ascertain, the sources and types of health-related data non-use, its implications for citizens and society and some of the reasons it occurs. It does this by focussing on issues with clinical care records, research data and governance frameworks and associated examples of non-use.
Graeme Laurie, 'Liminality and the limits of law in health research regulation: What are we missing in the spaces in-between?', (2017), Medical Law Review, Vol 25, pp 47-72
Abstract: This article fundamentally challenges the way in which law currently regulates human health research. It invokes the anthropological concept of liminality – the quality of in-between-ness – to suggest deeper ways of understanding ongoing challenges in delivering acceptable and effective regulation of research involving human participants. In stark contrast to the structural regulatory spaces constructed by law, the metaphor of the liminal space is explored to explain what is lost through our failure to see health research regulation as an inherently human experiential process, involving potentially profound transformative events for participants and researchers alike. The implications for the future of health research regulation are then examined. In particular, the analysis calls into question key features of the current regulatory paradigm, and demands that we reconsider our own demands of law in this context. The argument is made that health research is a liminal process and that we fail to treat it as such. This requires a rethink of corollary regulation also in processual terms. Ultimately, the charge is to undertake a radical reimagining of regulatory space to accommodate and promote liminal regulatory spaces.
Samuel Taylor-Alexander, Edward S. Dove, Agomoni Ganguli Mitra, Graeme Laurie, Isabel Fletcher, Catriona McMillan, 'Beyond regulatory compression: Confronting the liminal spaces of health research regulation', (2016), Law, Innovation and Technology, Vol 8, pp 149-176
Abstract: Biomedicine and the life sciences continuously rearrange the relationship between culture and biology. In consequence, we increasingly look for a suitable regulatory response to reduce perceived uncertainty and instability. This article examines the full implications of this ‘regulatory turn’ by drawing on the anthropological concept of liminality. We offer the term ‘regulatory compression’ to characterise the effects of extant regulatory approaches on health research practices. With its focus on transformation and the ‘in-between’, liminality allows us to see how regulatory frameworks rely on a silo-based approach to classifying and regulating research objects such that they: (1) limit the flexibility necessary in clinical and laboratory research; (2) result in the emergence of unregulated spaces that lie between the bounded regulatory spheres; and (3) and curtail modes of public participation in the health research enterprise. We suggest there is a need to develop the notion of ‘processual regulation’, a novel framework that requires a temporal-spatial examination of regulatory spaces and practices as these are experienced by all actors, including the relationship of actors with the objects of regulation.
Nayha Sethi, Graeme Laurie, Shawn Harmon, 'International academic conferences: Significance and legacy of the 13th World Congress of the International Association of Bioethics', (2016), Medical Law International, Vol 16, pp 105-114
Abstract: In June 2016, the University of Edinburgh hosted the 13th World Congress (IAB2016) of the International Association of Bioethics (IAB). It is critical both to reflect on the event past and to consider how we might keep future events relevant and to adequately bridge the periods in-between. In other words, how do we generate and maintain legacy and help to keep communities consistently engaged over time? This brief article undertakes these functions by reflecting on some of the lessons learned from IAB2016 in the hope that it will prove useful to future IAB Congress organizers (and indeed other international conference organizers).
Graeme Laurie, Leslie Stevens, 'Developing a Public Interest Mandate for the Governance and Use of Administrative Data in the United Kingdom ', (2016), Journal of Law and Society, Vol 43, pp 360–392
Abstract: This article addresses the legal and ethical uncertainties surrounding the use of administrative data for research. Drawing upon best practices developed by the authors in previous data initiatives and engagement with research communities, the article suggests a problematic organisational culture as the most significant barrier to proportionate and good governance of administrative data. Accordingly, the article offers a novel means for data custodians to identify key considerations by introducing a decision-making template that supports public authorities’ assessment of preparedness for data reuse through identification of challenges faced, related to sector-specific practices. As a catalyst for change, the authors advocate a public interest mandate - commitment to safely and ethically use administrative data when it is in the public interest to do so. This is delivered through implementation of the decision-making template, overt commitment to principles of public interest and proportionality, and engagement with stakeholders to address remaining areas of uncertainty.
Edward S. Dove, Isabel Fletcher, Agomoni Ganguli Mitra, Graeme Laurie, Catriona McMillan, Nayha Sethi, Annie Sorbie, Samuel Taylor-Alexander, 'Conference report: 13th World Congress of the International Association of Bioethics, Edinburgh 14-17 June 2016 (IAB2016)', (2016), SCRIPTed, Vol 13, pp 202-209
Graeme Laurie, Nathan Lea, Nicholls Jacqueline, Christine Dobbs, Nayha Sethi, James Cunningham, John Ainsworth, Martin Heaven, Trevor Peacock, Anthony Peacock, Kerina Jones, Dipak Kalra, 'Data safe havens and trust: Toward a common understanding of trusted research platforms for governing secure and ethical health research', (2016), JMIR Medical Informatics, Vol 4, pp e22
Abstract: In parallel with the advances in big data-driven clinical research, the data safe haven concept has evolved over the last decade. It has led to the development of a framework to support the secure handling of health care information used for clinical research that balances compliance with legal and regulatory controls and ethical requirements while engaging with the public as a partner in its governance. We describe the evolution of 4 separately developed clinical research platforms into services throughout the United Kingdom-wide Farr Institute and their common deployment features in practice. The Farr Institute is a case study from which we propose a common definition of data safe havens as trusted platforms for clinical academic research. We use this common definition to discuss the challenges and dilemmas faced by the clinical academic research community, to help promote a consistent understanding of them and how they might best be handled in practice. We conclude by questioning whether the common definition represents a safe and trustworthy model for conducting clinical research that can stand the test of time and ongoing technical advances while paying heed to evolving public and professional concerns.
Edward S. Dove, Agomoni Ganguli Mitra, Graeme Laurie, Catrinona McMillan, Samuel Taylor-Alexander, 'Elberte v. Latvia: Whose tissue is it anyway – Relational autonomy or the autonomy of relations?', (2016), Medical Law International, Vol 15, pp 77-96
Abstract: A European Court of Human Rights decision rendered in January 2015 (Elberte v. Latvia) has raised a curious question regarding the nature and scope of the right for relatives to consent to or to oppose the removal of a deceased person’s tissues. The decision suggests that Council of Europe member states must clearly define the scope of the right for relatives to express their preferences for removal of a deceased’s tissue or organs – provided such a right has been created in law – and member states must define the corresponding obligation or margin of discretion conferred on experts or other authorities to explain these rights to the relatives. Notwithstanding, this article asks whether the decision could open the door to a free-standing right for relatives to oppose removal of their deceased relative’s tissues or organs, regardless of the deceased person’s own wishes, in the name of the relatives’ human ‘right to respect for private life’.
Graeme Laurie, 'Pause for Reflection…and Respect ', (2015), SCRIPTed, Vol 12, pp 81
J M Wardlaw, H Davies, T C Booth, G Laurie, A Compston, C Freeman, M O Leach, Adam Waldman, D J Lomas, K Kessler, F Crabbe, A Jackson, 'Acting on incidental findings in research imaging ', (2015), BMJ, Vol 351, pp h5190
Graeme Laurie, J. Ainsworth, J. Cunningham, Christine Dobbs, Kerina H. Jones, D. Kaira, N. C. Lea, Nayha Sethi, 'On Moving Targets and Magic Bullets: Can the UK Lead the Way with Responsible Data Linkage for Health Research?', (2015), International journal of medical informatics, Vol 84, pp 933-940
Abstract: Purpose: To provide an overview of essential elements of good governance of data linkage for health-related research, to consider lessons learned so far and to examine key factors currently impeding the delivery of good governance in this area. Given the considerable hurdles which must be overcome and the changing landscape of health research and data linkage, a principled, proportionate, risk-based approach to governance is advocated.Discussion: In light of the considerable value of data linkage to health and well-being, the United Kingdom aspires to design and deliver good governance in health-related research. A string of projects have been asking: what does good governance look like in data linkage for health research? It is argued here that considerable progress can and must be made in order to develop the UK’s contribution to future health and wealth economies, particularly in light of mis-start initiatives such as care.data in NHS England. Discussion centres around lessons learned from previous successful health research initiatives, identifying those governance mechanisms which are essential to achieving good governance.Conclusion: This article suggests that a crucial element in any step-increase of research capability will be the adoption of adaptive governance models. These must recognise a range of approaches to delivering safe and effective data linkage, while remaining responsive to public and research user expectations and needs as these shift and change with time and experience. The targets are multiple and constantly moving. There is not – nor should we seek – a single magic bullet in delivering good governance in health research.
Shawn Harmon, Lawrence Gostin, Liz Grant, John Gillies, Graeme Laurie, 'Imagining global health with justice: Ebola, impoverished people and health systems', (2015), Medical Law International, Vol 15, pp 3-18
Graeme Laurie, Edward S. Dove, 'Consent and anonymisation: Beware binary constructions', (2015), BMJ, Vol 350, pp 350
Pam Carter, Graeme Laurie, Mary Dixon-Woods, 'The Social Licence for Research: Why care.data Ran Into Trouble', (2015), Journal of Medical Ethics, Vol 41, pp 404-409
Abstract: In this article we draw on the concept of a social licence to explain public concern at the introduction of care.data, a recent English initiative designed to extract data from primary care medical records for commissioning and other purposes, including research.The concept of a social licence describes how the expectations of society regarding some activities may go beyond compliance with the requirements of formal regulation; those who do not fulfil the conditions for the social licence (even if formally compliant) may experience ongoing challenge and contestation. Previous work suggests that people's cooperation with specific research studies depends on their perceptions that their participation is voluntary and is governed by values of reciprocity, non-exploitation and service of the public good. When these conditions arenot seen to obtain, threats to the social licence for research may emerge. We propose that care.data failed to adequately secure a social licence because of:(i) defects in the warrants of trust provided for care.data,(ii) the implied rupture in the traditional role,expectations and duties of general practitioners, and(iii) uncertainty about the status of care.data as a public good. The concept of a social licence may be useful in explaining the specifics of care.data, and also in reinforcing the more general lesson for policy-makers that legal authority does not necessarily command social legitimacy.
Graeme Laurie, Susan E Wallace, Elli G. Gourna, Osama Shoush, Jessica Wright, 'Respecting Autonomy Over Time: Policy and Empirical Evidence on Re-consent in Longitudinal Biomedical Research', (2015), Bioethics
Abstract: Re-consent in research, the asking for a new consent if there is a change in protocol or to confirm the expectations of participants in case of change, is an under-explored issue. There is little clarity as to what changes should trigger re-consent and what impact a re-consent exercise has on participants and the research project. This article examines applicable policy statements and literature for the prevailing arguments for and against re-consent in relation to longitudinal cohort studies, tissue banks and biobanks. Examples of re-consent exercises are presented, triggers and non-triggers for re-consent discussed and the conflicting attitudes of commentators, participants and researchers highlighted. We acknowledge current practice and argue for a greater emphasis on ‘responsive autonomy,’ that goes beyond a one-time consent and encourages greater communication between the parties involved. A balance is needed between respecting participants' wishes on how they want their data and samples used and enabling effective research to proceed.
Graeme Laurie, 'Recognizing the Right Not to Know: Conceptual, Professional, and Legal Implications', (2014), Journal of Law, Medicine and Ethics, Vol 42, pp 53-63
Abstract: This article argues for the importance of conceptual clarity in the debate about the so-called right not to know. This is vital both at the theoretical and the practical level. It is suggested that, unlike many formulations and attempts to give effect to this right, what is at stake is not merely an aspect of personal autonomy and therefore cannot and should not be reduced only to a question of individual choice. Rather, it is argued that the core interests that can be protected by the right not to know are better conceived of as privacy interests rather than autonomy interests. This not only helps us to understand what is in play but also informs regulatory, professional, and legal responses to handling information and taking decisions about whether or not to disclose information to persons about themselves. The practical implications of this conceptualization are explored in the context of feedback policies in health-related research.
Shawn Harmon, Graeme Laurie, Gill Haddow, 'Governing Risk, Engaging Publics, and Engendering Trust: New Horizons for Law and Social Science?', (2013), Science and Public Policy, Vol 40, pp 25-33
Abstract: Modern biosciences require governance frameworks capable of simultaneously managing risk, coping with uncertainty, combating ambivalence, and building trust, while encouraging the delivery of those instrumental outputs that we value/demand. This multi-dimensional task makes the design and delivery of good governance frameworks extremely difficult. Efforts to date have, by and large, failed, particularly where the law has been relied on. Preoccupation with risk has tended to shape regulatory systems, but the conception of risk relied on is deficient, and its use is often oriented to support precautionary approaches in the absence of ‘evidence’. Our collaborative efforts lead us to suggest that more robust mechanisms need to be deployed which reveal and promote interactions with a fuller gamut of risks. We argue for a reflexive mode of governance which addresses the dynamic nature of science and uses the law more effectively as a value- and institution-framing mechanism.
Graeme Laurie, Nayha Sethi, 'Towards Principles-Based Approaches to Governance of Health-Related Research Using Personal Data ', (2013), European Journal of Risk Regulation, Vol 2013, pp 43-57
Abstract: Technological advances in the quality, availability and linkage potential of health data for research make the need to develop robust and effective information governance mechanisms more pressing than ever before; they also lead us to question the utility of governance devices used hitherto such as consent and anonymisation. This article assesses and advocates a principles-based approach, contrasting this with traditional rule-based approaches, and proposes a model of principled proportionate governance. It is suggested that the approach not only serves as the basis for good governance in contemporary data linkage but also that it provides a platform to assess legal reforms such as the draft Data Protection Regulation.
Nayha Sethi, Graeme Laurie, 'Delivering Proportionate Governance in the Era of eHealth: Making Linkage and Privacy Work Together', (2013), Medical Law International, Vol 13, pp 168-204
Abstract: This article advances a principled proportionate governance model (PPGM) that overcomes key impediments to using health records for research. Despite increasing initiatives for maximising benefits of data linkage, significant challenges remain, including a culture of caution around data sharing and linkage, failure to make use of flexibilities within the law and failure to incorporate intelligent iterative design. The article identifies key issues for consideration and posits a flexible and accessible governance model that provides a robust and efficient means of paying due regard to both privacy and the public interests in research. We argue that proportionate governance based on clear guiding principles accurately gauges risks associated with data uses and assigns safeguards accordingly. This requires a clear articulation of roles and responsibilities at all levels of decision-making and effective training for researchers and data custodians. Accordingly, the PPGM encourages and supports defensible judgements about data linkage in the public interest.
Graeme Laurie, Emily Postan, 'Rhetoric or Reality: What is the Legal Status of Consent Forms in Medical Research?', (2013), Medical Law Review, Vol 21, pp 371-414
Abstract: This article addresses the unresolved conundrum of the legal status of consent forms used in research involving tissue samples or personal data. It identifies which rights participants might have by virtue of any consent form they have signed and which legal remedies might be available to them should the research depart from the terms of the original consent. The paper demonstrates that, although the legal status of consent forms is not clear in the UK, the landscape is evolving. We suggest that the growing legal protection afforded to autonomy and judicial recognition of individual property rights in tissues may offer opportunities for remedies in law where the regulatory regimes controlling uses of human tissue and personal data do not. However, we argue that in the governance of research relationships—which depend crucially on trust—resort to legal remedy may be undesirable. We suggest that treating consent as a one-off event that can be effectively captured in a written document—as the law tends to do—is an inappropriate and counter-productive approach. The aims of ethical research governance will be better served by seeing consent as continuing relational process, requiring on-going mutual respect, opportunity for communication, and accommodation of changing circumstances. The consent form is merely a framing instrument and only the starting point for a partnership that will evolve over time. Crucially, the limits of consent must be recognised in the design and governance of modern research practices. The article concludes with recommendations to reconceive consent in these terms.
Graeme Laurie, Shawn Harmon, Fabiana Arzuaga, 'Foresighting Futures: Law, New Technologies, and the Challenges of Regulating for Uncertainty', (2012), Law, Innovation and Technology, Vol 4, pp 1-33
Abstract: This paper is concerned with making law more effective in its social operation and in its relationship with dynamic, complex and uncertain science. It explores how we might better regulate by considering the concept and role of 'legal foresighting'. It argues that legal foresighting is eminently justifiable and needs to be expanded, enhanced, and vastly improved. It offers a framework for performing legal foresighting in the face of new and emerging technologies, drawing in particular on the authors' experience in the bioscience and biotechnologies context.
Aidan Courtney, Paul de Sousa, Carol George, Graeme Laurie, Joyce Tait, 'Balancing open source stem cell science with commercialization ', (2011), Nature Biotechnology, Vol 29, pp 115-116
Graeme Laurie, 'Reflexive Governance in Biobanking: On the Value of Policy Led Approaches and the Need to Recognise the Limits of Law', (2011), Human Genetics, Vol 130, pp 347-356
Abstract: Although a few jurisdictions around the world have legislated in response to the phenomenon of biobanking, the far more common response has been policy led with funders and other stakeholders initiating multi-level policy initiatives to guide biobanking practice. An example of this is UK Biobank which has developed and operates according to an Ethics and Governance Framework. Such an instrument has no basis in law and yet it has played a crucial role in the set up and ongoing management of the resource. It will continue to do so, as related policies emerge, such as access and intellectual property policies. Numerous biobanking initiatives have similar high-level policy documents that guide decisions and practice. These are often framed as a commitment to participants, researchers and society more broadly and invoke notions such as the public good and the public interest. As such, they serve as a benchmark against which to measure a biobank’s performance. Moreover, policies become an important means by which biobankers are held accountable. This article critically analyses this policy-driven phenomenon asking how effectively policy—often as an alternative to law—serves to police and to promote biobanking. It argues that a policy of reflexive governance—defined and developed herein—can best meet the challenges faced by many biobanks and without the need for recourse to law.
Shawn H. E. Harmon, Graeme Laurie, 'Yearworth v. North Bristol NHS Trust: Property, Principles, Precedents and Paradigms', (2010), Cambridge Law Journal, Vol 69, pp 476-93
Graeme Laurie, 'Managing Access to Biobanks: How Can We Reconcile Privacy and Public Interests in Genetic Research?', (2010), Medical Law International, Vol 10, pp 315-337
Ken Mason, Graeme Laurie, 'Assistance in Dying or Euthanasia?: Comments on the End of Life Assistance (Scotland) Bill', (2010), Edinburgh Law Review, Vol 14, pp 493-97
Graeme Laurie, 'Learning Lessons and Making Differences: The European Association of Health Law Conference 2009', (2010), European Journal of Health Law, Vol 17, pp 295-298
Abstract: The second conference of the European Association of Health Law took place in the Royal College of Physicians in Edinburgh, Scotland on 15-16 October 2009. The event was generously sponsored by the British Academy and the AHRC/SCRIPT research centre based in the School of Law at the University of Edinburgh. The meeting was attended by 115 delegates from 26 countries and preceded by a public debate on assisted dying. This report gives an account of these events and the future direction of the work of the Association.
Graeme Laurie, Kathryn G. Hunter, 'Mapping, Assessing and Improving Legal Preparedness for Pandemic Flu in the United Kingdom ', (2009), Medical Law International, Vol 10, pp 101-138
Abstract: This article assesses the legal framework within which responses are deployed in the United Kingdom in the face of a pandemic such as the current H1N1 crisis or some other public health emergency. It begins with an account of the importance of legal preparedness as an essential feature of public health preparedness. It moves to an outline of the key legal provisions and parameters which provide the architecture for the existing framework in the UK, both domestically and internationally; thereafter, it identifies relevant factors that can be used to assess the efficacy of current legal preparedness, drawing on comparative experiences. Finally, it offers recommendations on how legal preparedness could be improved within the United Kingdom and in line with international obligations.
Timothy Caulfield, Amy Zarzeczny, Jennifer McCormick, Tania Bubela, Christine Critchley, Edna Einsiedel, Jacques Galipeau, Shawn Harmon, Michael Huynh, Insoo Hyun, Judy Illes, Rosario Isasi, Yann Joly, Graeme Laurie, Geoff Lomax, Holly Longstaff, Michael McDonald, Charles Murdoch, Ubaka Ogbogu, Jason Owen-Smith, Shaun Pattinson, Shainur Premji, Barbara Tigerstrom, David E. Winickoff, 'The Stem Cell Research Environment: A Patchwork of Patchworks', (2009), Stem Cell Reports, Vol 5, pp 82-88
Abstract: Few areas of recent research have received as much focus or generated as much excitement and debate as stem cell research. Hope for the therapeutic promise of this field has been matched by social concern associated largely with the sources of stem cells and their uses. This interplay between promise and controversy has contributed to the enormous variation that exists among the environments in which stem cell research is conducted throughout the world. This variation is layered upon intra-jurisdictional policies that are also often complex and in flux, resulting in what we term a 'patchwork of patchworks'. This patchwork of patchworks and its implications will become increasingly important as we enter this new era of stem cell research. The current progression towards translational and clinical research among international collaborators serves as a catalyst for identifying potential policy conflict and makes it imperative to address jurisdictional variability in stem cell research environments. The existing patchworks seen in contemporary stem cell research environments provide a valuable opportunity to consider how variations in regulations and policies across and within jurisdictions influence research efficiencies and directions. In one sense, the stem cell research context can be viewed as a living experiment occurring across the globe. The lessons to be gleaned from examining this field have great potential for broad-ranging general science policy application.
Graeme Laurie, 'Role of the UK Biobank Ethics and Governance Council ', (2009), The Lancet, Vol 374, pp 1676
Graeme Laurie, 'Consent for Biobanking ', (2008), BMJ, Vol 337, pp 186-187
Graeme Laurie, 'Evidence of Support for Biobanking Practices ', (2008), BMJ, Vol 337, pp 186-187
Graeme Laurie, 'The European Association of Health Law: Addressing Unmet Needs in Policy, Practice and Research', (2008), European Journal of Health Law, Vol 15, pp 251-259
Graeme Laurie, 'Fore-warned is Fore-armed: Is Intellectual Property a Suitable Case for Foresight?', (2008), International Review of Intellectual Property and Competition Law, Vol 39, pp 507-510
Graeme Laurie, Gill Haddow, Sarah Cunningham-Burley, Kathryn Hunter, 'Tackling Community Concerns about Commercialisation and Genetic Research: A Modest Interdisciplinary Proposal', (2007), Social Science and Medicine, Vol 64, pp 272-282
Abstract: 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.
Graeme Laurie, 'Ownership of Genetic Material and Information ', (2006), eLS
Abstract: The legal position on ownership of genetic material is a complex issue. The ethical issues surrounding the application of property rights to human genetic material also have to be considered.
Graeme Laurie, Renate Gertz, 'When Worlds Collide: What are theOobligations of the NHS at the Interface between Data Protection and Freedom of Information Regimes?', (2006), Edinburgh Law Review, Vol 10, pp 151-55
Renate Gertz, Shawn Harmon, Graeme Laurie, Geoff Pradella, 'Developments in Medical Law in the United Kingdom in 2005 and 2006 ', (2006), European Journal of Health Law, Vol 13, pp 143-158
Abstract: This article highlights and summarises the key developments in medical law in the jurisdictions of the United Kingdom in 2005 and to April 2006. Topics are mental health and mental capacity, data protection, freedom of information and the impact on health data, the Human Tissue Act, genetic research databanks, Human Fertilisation and Embryology Act--Review of the legislation, consultations and related case law, developments in embryo and embryonic stem cell research, clinical trials and human subject research, medical futility, and physician assisted dying.
Graeme Laurie, 'Physician Assisted Suicide in Europe: Some Lessons and Trends', (2005), European Journal of Health Law, Vol 12, pp 5-10
Graeme Laurie, Ken Mason, 'Personal Autonomy and the Right to Treatment: A Note on R on the Application of Burke v General Medical Council', (2005), Edinburgh Law Review, Vol 9, pp 123-32
Abstract: Our first reading of Burke was in The Times when one’s immediate reaction was to question the precise nature of Munby J’s judgment – were it and its consequences directed to the specific problems of providing and withdrawing artificial nutrition and hydration (ANH) from dying patients or were the judge’s observations and conclusions to be read as being applicable across the whole spectrum of medical care of the terminally ill? Was it indeed the case, unlikely though it seemed, that a right to treatment had been established with scant regard for the attendant resource implications? It was assumed that these questions would be answered when the full transcript was available – and the major aim of this analysis is to discern whether or not this assumption was justified.
Graeme Laurie, 'Should There Be an Obligation of Disclosure of Origin of Genetic Resources in Patent Applications?: Learning Lessons from Developing Countries', (2005), SCRIPTed, Vol 2, pp 306-16
Abstract: The article discusses whether there should be an obligation of disclosure of origin of genetic resources in patent applications. In particular, Laurie comments on the evolving relations of the intellectual property world and the role of the World Intellectual Property Organisation (WIPO) in the international policy debate on such matters. The difficulties of the interconnectedness of the patent system and the Convention on Biological Diversity are considered, with the possible implications of an obligation of disclosure for the future of patent law, and international laws and policy.
Graeme Laurie, 'The Right not to Know: An Autonomy Based Approach - A Response to Andorno', (2004), Journal of Medical Ethics, Vol 30, pp 439-40
Abstract: The author comments on the question of a right not to know genetic information, in a response to Dr Adorno. The article discusses similaries shared between Laurie and Adorno, with the former differentiating his views by focussing on a privacy based approach, as opposed to an autonomy based approach.
Graeme Laurie, 'Genetic Databases: Assessing the Benefits and the Impact on Human and Patient Rights - A WHO Report', (2004), European Journal of Health Law, Vol 11, pp 87–92
Graeme Laurie, 'Patenting Stem Cells of Human Origin ', (2004), European Intellectual Property Review, Vol 26, pp 59-66
Abstract: The author discusses the impact of the European Union's Directive for the legal protection of biotechnological inventions (Directive 98/44/EC of 6 July 1998. Specific attention is given to the absence from provisions of the mention of human stem cells, which generated significant ethical and legal debate in the UK, and globally, at that time. The paper considers the robustness of European patent provisions, and focusses on the potential consequences in the continuing debate of human stem cells.
Graeme Laurie, Ken Mason, 'Misfeasance in Public Office: An Emerging Medical Law Tort?', (2003), Medical Law Review, Vol 11, pp 194-207
Abstract: The authors draw on two notable cases, Akenzua v. Secretary of State for the Home Department, and Palmer v Tees Health Authority, to which the outcome has prompted the article discussing misfeasance as an emerging medical law tort. Although similarities exists in both cases, they are quite different, with the former argued on the basis of misfeasance in public office, and the latter on negligence. These are examined in detail, together with their possible impact for an NHS Trust.
Graeme Laurie, 'Ethics Watch: DNA Theft: A New Crime in the UK', (2003), Nature Reviews Genetics, Vol 4, pp 584
Graeme Laurie, 'Better to Hesitate at the Threshold of Compulsion: PKU Testing and the Concept of Family Autonomy in Eire', (2002), Journal of Medical Ethics, Vol 28, pp 136-138
Graeme Laurie, 'Pharmacogenomics and Human Rights ', (2002), Biotechnology Investment Today, Vol Spring, pp 60-65
Graeme Laurie, 'Medical Records Linkage: When is it Lawful and in the Public Interest', (2002), E-L@w Review, pp 5-6
Graeme Laurie, 'Intellectual Property and the Human Genome ', (2001), Chartered Institute of Patent Agents Journal, pp 352-54
Graeme Laurie, 'Owning the Genome ', (2001), Science and Public Affairs, pp 10-11
Graeme Laurie, Ken Mason, 'Consent or Property: Dealing with the Body and its Parts in the Shadow of Bristol and Alder Hey', (2001), Modern Law Review, Vol 64, pp 710-729
Abstract: This article first considers the tenuous base on which the law of property in the body is founded, and then discusses the practical results of this in the light of the recent furore surrounding events at Bristol and Alder Hey. The authors suggest that neither the consent-based model followed by the official inquiries into these events nor a possible policy based on a full-blown property model adequately cover the private rights of an individual's next of kin or the right of the public to an efficient and reliable pathological service within the NHS. Rather, they propose that a combined model in which a 'cascade of possession' for the recognition of various property interests is initiated by assent on the part of the next of kin and terminates in full possession of the body vested in the executor for the purposes of its disposal. The authors recommend further that any reform of the law should apply property rights to body parts taken from both the living and the dead.
Graeme Laurie, 'Challenging Medical Legal Norms: The Role of Autonomy, Confidentiality and Privacy in Protecting Individual and Familial Group Rights in Genetic Information', (2001), Journal of Legal Medicine, Vol 22, pp 1-54
Abstract: In this article, Laurie discusses the impact of generating genetic information, and what the consequences are of this for individuals, and family members, whose familial genetic information is shared. The authors considers who controls access to such information, the rights and interests that arise from a group claim to familial data. The competing "right to know" versus "the right not to know" are examined in relation to genetic data, along with the role of confidentiality and autonomy. Finally, the article ends with a note on privacy and legislative considerations this may pose.
Graeme Laurie, 'Review - Protecting Privacy ', (2000), Law Quarterly Review, Vol 116, pp 173-79
Graeme Laurie, 'Genetic Discrimination: How Does UK Law Measure Up?', (2000), Genetics Law Monitor, pp 6-7
Graeme Laurie, 'Protecting and Promoting Privacy in an Uncertain World: Further Defences of Ignorance and the Right Not to Know', (2000), European Journal of Health Law, Vol 7, pp 185-191
Graeme Laurie, 'Review - Law and Human Genetics ', (2000), Journal of the Law Society of Scotland, Vol 45, pp 41
Graeme Laurie, Michael Grodin, 'Susceptibility Genes and Neurological Disorders: Learning the Right Lessons from the Human Genome Project', (2000), Archives of Neurology, Vol 57, pp 1569-1574
Graeme Laurie, 'Genetics and Patients' Rights: Where are the Limits?', (2000), Medical Law International, Vol 5, pp 25-44
Graeme Laurie, Michael Grodin, 'Review: Against Relativism: Cultural Diversity and the Search for Ethical Universals in Medicine', (2000), Perspectives in Biology and Medicine, Vol 43, pp 627-29
Graeme Laurie, Ken Mason, 'Negative Treatment of Vulnerable Patients: Euthanasia by any other Name?', (2000), Juridical Review, pp 159-78
Abstract: In this article the authors follow up their work entitled 'The Management of the Persistent Vegetative State in the British Isles' (1996 J. R. 263) in which they argued that the foundations of a slippery slope in respect of the treatment of patients in PVS had been laid in both Scots and English law. They now trace legal developments since 1996 and consider them in the light of recent guidance from the British Medical Association which purports to extend the application of existing legal precedents beyond those in PVS so as to encompass withdrawal of artificial feeding and hydration from other severely incapacitated patients, such as those suffering from stroke or dementia. Finally, the provisions of the Adults with Incapacity (Scotland) Act 2000 are examined to determine to what extent, if any, they erect barriers on the moral and legal slippery slope in respect of negative treatment decisions involving vulnerable patients.
Graeme Laurie, 'Wielding the Implement of Law: Distilling New Rights and Responsibilities in the Age of the 'New Genetics'', (1999), Health, Risk & Society, Vol 1, pp 333-41
Abstract: The law has, to date, been slow to respond to advances in genetics, but in many ways this may be propitious. History teaches us that there is an ever-present risk that the law will be used merely to embody knee-jerk reactions to new developments in medicine and science, frequently to the detriment of all interested parties. Adequate and appropriate legal responses to genetic research can only come once a full debate on the problems to be addressed has taken place, and when society as a whole is appraised of the options at hand. This article offers an overview of the problems which are thrown up for the law by 'new genetics', including the problem of reconciling competing claims to genetic information from family members, insurers and employers, as well as the dilemma of determining how to regulate the potential range of uses of new genetic knowledge. The article offers some views on how we might use the law to proceed sensibly and productively in the future.
Graeme Laurie, 'In Defence of Ignorance: Genetic Information and the Right Not to Know', (1999), European Journal of Health Law, Vol 6, pp 119-132
Graeme Laurie, 'Obligations Arising from Genetic Information: Negligence and the Protection of Familial Interests', (1999), Child and Family Law Quarterly, Vol 11, pp 109-24
Graeme Laurie, 'Parens Patriae Jurisdiction in the Medico-legal Context: The Vagaries of Judicial Activism', (1999), Edinburgh Law Review, Vol 3, pp 95-107
Graeme Laurie, 'Robert H Dickson, Medical and Dental Negligence (Edinburgh: T & T Clark, 1997) ', (1998), Edinburgh Law Review, Vol 2, pp 243-45
Graeme Laurie, 'Review - Trade Related Aspects of Intellectual Property Rights: A Concise Guide to the TRIPS Agreement ', (1998), International Journal of Law and Information Technology, Vol 6, pp 245-46
Graeme Laurie, 'Intellectual Property Rights and the Interests of Indigenous Peoples ', (1997), Lesotho Law Journal, Vol 10, pp 107-26
Graeme Laurie, Graeme P. Adam, 'Legal aspects of venepuncture ', (1996), Postgraduate Medical Journal, Vol 72, pp 768
Graeme Laurie, 'The Most Personal Information of All: An Appraisal of Genetic Privacy in the Shadow of the Human Genome Project', (1996), International Journal of Law, Policy and the Family, Vol 10, pp 74-101
Graeme Laurie, Ken Mason, 'The Management of Persistent Vegetative State in the British Isles ', (1996), Juridical Review, pp 263-83
Graeme Laurie, 'Book Review: AIDS: A Guide to the Law (2nd edn)', (1996), Medical Law International, Vol 2, pp 183-87
Graeme Laurie, 'An End to Error of Law in Unjust Enrichment: Morgan Guaranty Trust Company of New York v. Lothian Regional Council', (1995), Juridical Review, pp 244-47
Philippa Gannon, Tom Guthrie, Graeme Laurie, 'Patents, Morality and DNA: Should there be Intellectual Property Protection of the Human Genome Project?', (1995), Medical Law International, Vol 1, pp 321-45
Abstract: This article examines the appropriateness of using existing patent laws in various jurisdictions in an effort to secure protection of the work currently being carried out on the Human Genome Project. Certain ethical and practical problems which arise from current practices in Europe, USA and Japan are explored.It is submitted that the nature of the problems are such that it might be appropriate to consider alternative means of rewarding those involved in unravelling human DNA. An attempt is made to outline some appropriate matters to consider in developing such an alternative.
Graeme Laurie, 'Automatism and Insanity in the Laws of England and Scotland ', (1995), Juridical Review, pp 253-65
Abstract: This article examines the nature and scope of the defence of automatism in the criminal laws of England and Scotland and seeks to demonstrate how the defence has developed as a result of an over-reliance on the concept of insanity as defined in each system. It will be shown that this has led to the inappropriate application of legal concepts to persons suffering from certain medical conditions with unforeseen and undesirable results, both for the law and for those afflicted. Finally, comment is made on recent developments which have led to uncertainty about the future of the defence in Scotland.
Graeme Laurie, 'Damages, Duty and Hamilton v. Fife Health Board ', (1994), Juridical Review, pp 110-12
Leslie Stevens, Christine Dobbs, Kerina H. Jones, Graeme Laurie, 'Dangers from within? Looking inwards at the role of maladministration as the leading cause of health data breaches in the UK' in Data Protection and Privacy (Springer 2017) 1-29
Abstract: Despite the continuing rise of data breaches in the United Kingdom’s health sector there remains little evidence or understanding of the key causal factors leading to the misuse of health data and therefore uncertainty remains as to the best means of prevention and mitigation. Furthermore, in light of the forthcoming General Data Protection Regulation, the stakes are higher and pressure will continue to increase for organisations to adopt more robust approaches to information governance. This chapter builds upon the authors’ 2014 report commissioned by the United Kingdom’s Nuffield Council on Bioethics and Wellcome Trust’s Expert Advisory Group on Data Access, which uncovered evidence of harm from the processing of health and biomedical data. One of the review’s key findings was identifying maladministration (characterised as the epitome of poor information governance practices) as the number one cause for data breach incidents. The chapter uses a case study approach to extend the work and provide novel analysis of maladministration and its role as a leading cause of data breaches. Through these analyses we examine the extent of avoidability of such incidents and the crucial role of good governance in the prevention of data breaches. The findings suggest a refocus of attention on insider behaviours is required, as opposed to, but not excluding, the dominant conceptualisations of data misuse characterised by more publicised (and sensationalised) incidents involving third-party hackers.
Edward S. Dove, Graeme Laurie, Bartha M. Knoppers, 'Data sharing and privacy ' in Geoffrey Ginsburg, Huntington Willard (ed.) Genomic and Personalized Medicine (Elsevier 2016) 143-160
Abstract: As various stakeholders in biomedical research and clinical practice laudably move toward a data sharing culture, challenges arise. In particular, privacy and data privacy regulation play a large role in defining the proper contours of global data sharing. In this chapter, we outline the practices and benefits of genomic and clinical data sharing; the dimensions of privacy and data privacy regulation that challenge data sharing; and the ways in which one organization, the Global Alliance for Genomics and Health, is addressing these challenges.
Graeme Laurie, Ken Mason, 'Waxing and Waning The Shifting Sands of Autonomy on the Medico-Legal Shore' in Catherine Stanton, Sarah Devaney, Anne-Maree Farrell, Alexandra Mullock (ed.) Pioneering Healthcare Law (Taylor & Francis 2015) 19-30
Graeme Laurie, J. Kenyon Mason, 'Trust or contract How far does the contemporary doctor-patient relationship protect and promote autonomy?' in Pamela Ferguson, Graeme Laurie (ed.) Inspiring a Medico-Legal Revolution (Ashgate Publishing 2015) 73-94
Abstract: The law has intervened extensively in the last 30 years in the name of autonomy enhancement and the protection of those with reduced mental capacity. It is, however, far from clear how much this has resulted in a net increase in the substantial trust that patients feel towards healthcare professionals - indeed, the opposite might be true. This chapter considers these developments against the backdrop of Sheila McLean's contributions on the topics of consent and autonomy. It argues that a failure by law and its institutions to grasp the nuances and contours of authentic autonomy has encouraged a pseudo-contractual doctor-patient dynamic in which patient abandonment is legally sanctioned and the spectre of paternalism remains. While recognising that law cannot prescribe trust, it nonetheless suggests ways in which law's future direction of travel could be more conducive to the promotion of a genuine therapeutic partnership.
Graeme Laurie, Shawn Harmon, 'Through the Thicket and Across the Divide Successfully Navigating the Regulatory Landscape in Life Sciences Research' in Emilie Cloatre, Martyn Pickersgill (ed.) Knowledge, Technology and Law (Routledge 2014) 121-36
Graeme Laurie, 'Privacy and the Right Not to Know A Plea for Conceptual Clarity' in Ruth Chadwick, Mairi Levitt, Darren Shickle (ed.) The Right to Know and the Right Not to Know (Cambridge University Press 2014) 38-52
Graeme Laurie, 'Patenting and the Human Body ' in Ian Kennedy, Andrew Grubb, Judith Laing, Jean McHale (ed.) Principles of Medical Law (Oxford University Press 2010) 1051-1086
Graeme Laurie, Adrienne Hunt, Martin Richards, 'UK Biobank Ethics and Governance Council An Exercise in Added Value' in Jane Kaye, Mark Stranger (ed.) Principles and Practice in Biobank Governance (Ashgate Publishing 2009) 229-242
Graeme Laurie, 'The UK Biobank Ethics and Governance Council How Valuable is an “Ethics+” A Approach to Governance?' in Kris Dierickx, Pascal Borry (ed.) New Challenges for Biobanks (Intersentia 2009) 239-248
Graeme Laurie, Katherine G. Hunter, 'Involving Publics in Biobank Governance Moving Beyond Existing Approaches' in Heather Widdows, Caroline Mullen (ed.) The Governance of Genetic Information (Cambridge University Press 2009) 151-77
Abstract: This chapter examines the crucial issue of how to include people well in biobank governance. We use the example of UK Biobank to illustrate our discussion because it is ground-breaking in its approach to governance and because, in terms of public engagement, the project has been criticised for its approach to public consultation. In reaction to these perceived failings there have been calls for greater participant involvement in the running and oversight of UK Biobank. More particularly, and more recently, Winickoff has proposed a ‘shareholder model’ which seeks to ‘… move beyond public consultation to embrace participatory forms of resource entitlement’. Winickoff draws on corporate modelling to argue for more direct representation of UK Biobank participants in the project's decision making and governance processes. As such, he argues that public engagement must move from consultation to representation. In other realms, representation itself is found wanting, with writers such as Pimbert and Wakeford arguing that engagement exercises ‘in the design of technologies’ should embrace deliberative democratic practices to ‘… democratize [sic] policy making by moving beyond representative democracy and traditional forms of consultation’. We examine these calls to move beyond consultation to representation and from representation to more deliberative and inclusive processes of participation. Perhaps ironically, we agree with Winickoff that there is value in models from the corporate sphere; not on a shareholder approach, however, but on a stakeholder approach which goes beyond even that which is proposed in the discourse on deliberative democracy. Moreover, and despite early criticisms of UK Biobank, we find valuable evidence within that model of what it means to involve people well.
Graeme Laurie, 'Personality, Privacy and Autonomy in Medical Law ' in Niall Whitty, Reinhard Zimmermann (ed.) Rights of Personality in Scots Law (Dundee University Press 2009) ch 9
Graeme Laurie, Ann Bruce, Catherine Lyall, 'The Roles of Values and Interests in the Governance of the Life Sciences Learning Lessons from the ‘Ethics+’ Approach of UK Biobank' in Catherine Lyall, James Smith, Theo Papaioannou (ed.) The Limits to Governance (Ashgate Publishing 2009) 51-78
Graeme Laurie, 'Patents, Patients and Consent Exploring the Interface between Regulation and Innovation Regimes' in Han Somsen (ed.) The Regulatory Challenge of Biotechnology (Edward Elgar Publishing 2007) 214-37
Graeme Laurie, 'The Autonomy of Others Reflections on the Rise and Rise of Patient Choice in Contemporary Medical Law' in 'First Do No Harm' (Ashgate Publishing 2006) 131-49
Abstract: The author, Laurie, provides an account of the writings of Professor (Emiritus) of Forensic Medicine and Honorary Fellow, Professor J Kenyon Mason. In this chapter, an extract from Professor Mason's Festschrift, Laurie focusses specifically on Mason's writings on personal autonomy within the field of Medical Law. It draws on a retrospective of cases, of significance in Mason's writings, and considers what the implications are for the future of medical law.
Graeme Laurie, 'Genetic Testing and the Criminal Law in the United Kingdom ' in Don Chalmers (ed.) Genetic Testing and the Criminal Law (UCL Press 2005) 187-239
Graeme Laurie, 'Challenging Medical Legal Norms The Role of Autonomy, Confidentiality and Privacy in Protecting Individual and Familial Group Rights in Genetic Information' in Sheila A. M. McLean (ed.) Genetics and Gene Therapy (Ashgate Publishing 2005)
Graeme Laurie, 'Patenting and the Human Body ' in A. Grubb (ed.) Principles of Medical Law (Oxford University Press 2004) 1079-101
Abstract: In this extract from 'Principles of Medical Law', Laurie considers the current state of play regarding the influence on medical law of patent law and patent rights. Laurie goes on to consider possible restrictions and grounds for objection in being granted a patent. Comparison is made across jurisdictions as to what constitutes a discovery; moral considerations of granting patents; and interpretation of patent requests. The chapter closes with a section on the access to medicines debate and the international dimension.
Graeme Laurie, Kathryn Hunter, 'Benefit Sharing and Public Trust in Genetic Research ' in Gardar Arnason, Salvor Nordal, Vilhjalmur Arnason (ed.) Blood and Data (University of Iceland Press 2004)
Graeme Laurie, 'Privacy and Property? Multi-level Strategies for Protecting Interests in Genetic Material' in Bartha Maria Knoppers, Charles R. Scriver (ed.) Genomics, Health and Society (Policy Research Initiative, Canada 2003) 83-98
Abstract: The paper builds on earlier medico-legal work by Laurie on privacy in relation to genetic material. In this chapter, the author discusses not only Laurie's views as 'pro-privacy' but the limitations of privacy, particularly once information, genetic or otherwise, enters a public sphere. The article draws on cases and laws in the UK, continental Europe, and the US, to provide a comparative view in suggesting an alternative approach to privacy.
Graeme Laurie, 'Privacy, Property or Permission Need our Models for Regulating Personal Genetic Material Be Mutually Exclusive' in S. Lesavich (ed.) Law and Technology (ACTA Press 2002) 16-22
Abstract: The argument considers in favour of the extension of property rights to individuals in respect of their genetic materials and information derived from those materials. Laurie suggests that existing medico-legal paradigms do not offer sufficient privacy protection for individuals over information gleaned from their genetic material. The author also discusses the lack of public confidence in genetic research, acknowledging the value of participation into genetic and medical research to the scientific community. He draws on cases and comparative law to consider the role of a property model in the thesis.
Graeme Laurie, 'Medical Law and Human Rights Passing the Parcel Back to the Profession?' in Human Rights and Scots Law (Hart Publishing 2002) 245-74; 343-44
Graeme Laurie, 'Medical Genetics ' in Norman Cadenhead Muir, James Douglas Bell (ed.) A Century of Care (Medical and Dental Defence Union of Scotland 2002) 189-95
Graeme Laurie, 'Legal and Ethical Implications of Life Extension Techniques ' in New Research into the Treatment of Cancer and Age-Related Disease (Institute of Nanotechnology/DTI Biotechnology Division/Cancer Research Campaign 2002) 60-64
Graeme Laurie, 'Law, Ethics and Genetics ' in Eric C. R. Reeve (ed.) Encyclopedia of Genetics (Fitzroy Dearborn 2001) 594-605
Graeme Laurie, 'Permanent Vegetative State An Exercise in Legal Uncertainty' in Competency and Consent in Vulnerable Persons (Law Society of Scotland and British Medical Association 2000) 77-88
Graeme Laurie, 'Body as Property ' in J. K. Mason, Alexander McCall Smith (ed.) Law and Medical Ethics (Butterworths 1999) 485-97
Graeme Laurie, 'Prenatal Screening and Wrongful Life ' in J. K. Mason, Alexander McCall Smith (ed.) Law and Medical Ethics (Butterworths 1999)
Graeme Laurie, 'Civil Litigation following Injury and Death from Trauma The Health Care Professional in Jeopardy' in J. K. Mason, B. N. Purdue (ed.) The Pathology of Trauma (Arnold 1999) 408-503
Graeme Laurie, 'Genetic Information and the Law ' in J. K. Mason, Alexander McCall Smith (ed.) Law and Medical Ethics (Butterworths 1999) 167-88
Graeme Laurie, 'Consent ' in J. K. Mason, Alexander McCall Smith (ed.) Law and Medical Ethics (Butterworths 1999)
Graeme Laurie, 'Biotechnology Facing the Problems of Patent Law' in Hector MacQueen, Brian G. M. Main (ed.) Innovation, Incentive and Reward (Edinburgh University Press 1997) 45-63
Graeme Laurie, 'Biotechnology and Intellectual Property A Marriage of Inconvenience?' in Sheila A. M. McLean (ed.) Contemporary Issues in Law, Medicine and Ethics (Aldershot, Dartmouth 1996) 237-67
Graeme Laurie, Leslie Stevens, Kerina H. Jones, Christine Dobbs, 'Better use of data in government consultation ' 2016
Leslie Stevens, Graeme Laurie, 'The Administrative Data Research Centre Scotland: A Scoping Report on the Legal & Ethical Issues Arising from Access & Linkage of Administrative Data' 2014
Abstract: 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.
Graeme Laurie, Shawn Harmon, 'Through the Thicket and Across the Divide: Successfully Navigating the Regulatory Landscape in Life Sciences Research' 2013
Abstract: 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.
Graeme Laurie, Nayha Sethi, 'Information Governance of Use of Health-Related Data in Medical Research in Scotland: Towards a Good Governance Framework' 2012
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.
Graeme Laurie, Nayha Sethi, 'Information Governance of Use of Health-Related Data in Medical Research in Scotland: Current Practices and Future Scenarios' 2011
Abstract: This paper has been prepared as part of the governance work stream of the Scottish Health Informatics Programme (SHIP). It is intended as a platform for discussion and further elaboration with colleagues and those interested in issues surrounding the governance of secondary uses of health data for research. The main aims of the paper are two-fold. First, to offer an ethical, legal and social account of the current regulatory framework governing the use of person identifiable information (PII) for medical research in Scotland. It does so by both mapping out the legislation and key actors involved in governance, as well as illustrating how the framework is perceived to work in practice.A second aim of the report is to suggest a template to be used in the assessment of good governance. This template can be used both to evaluate current practices and to test any proposals for change in approaches to governance in Scotland and elsewhere with respect to uses of patient data for research purposes. It is anticipated that this template will be developed and refined with input from SHIP colleagues (particularly those at Information and Statistics Division (ISD) of NHS Scotland and those involved in the SHIP Systematic Review) as well as other stakeholders. This is the first in a series of papers in the governance stream of the SHIP programme, funded by the Welcome Trust. Future papers will address the design challenges of a new system of information governance for health-related medical research in Scotland.