Guthrie Cards in Scotland: Ethical, Legal and Social Issues

CHAPTER 1 - INTRODUCTION

1.1 This report explores the ethical, legal and social issues surrounding the existence, continued storage and future uses of the Guthrie cards collection held in Scotland. The report has been prepared by Professor Graeme Laurie¹ and Dr Kathryn Hunter² under the auspices of the School of Law, University of Edinburgh, and includes a chapter on public attitudes and engagement from Professor Sarah Cunningham-Burley³, Centre for Population Health Sciences, University of Edinburgh.

1.2 The evidence-base for this report has been developed from a literature review of pertinent legal and sociological materials; from an analysis of existing guidance and relevant documentation; from a comparative exploration of practices in other countries, and through discussions with key stakeholders, including the custodians of the collection. In the course of research the following persons and bodies were consulted: Mr David Aitken, Director and Ms Joan MacKenzie, Screening Co-ordinator, The Scottish Newborn Screening Laboratory; Mr David Edward, the Human Tissue Authority; Ms Patricia Ruddy, Information Services Division, NHS National Services Scotland; Ms Christine Cavanagh, Programme Manager, UK Newborn Screening Programme Centre; Dr Deirdre Madden, Senior Lecturer in Law, University College Cork, Professor James Chalmers, Glasgow Law School; Mr Gerard Porter, Edinburgh Law School; and Dr Mark Taylor & Ms Jessica Wright, Sheffield Law School, respectively Principal Investigator and Research Coordinator of the European Commission Privileged project.⁴ We are grateful to all parties for their time and contributions, including participants in a roundtable discussion on 21 January 2010 on an earlier draft of this report. Before and since then we have benefited from input from colleagues in Scottish Government - Gill Clark, Craig Gilbert and Vivian Leacock - who have worked with us over the years as governance arrangements within Scotland have developed. The inspiration for this work came from Dr Rosalind Skinner, Principal Medical Officer, Scottish Government (2009).

1.3 The Scottish Guthrie card collection began in 1965 and now contains more than 2.5 million cards which include blood/DNA samples and personal information relating to children born in Scotland since the inception of the collection until the present day. Numerous purposes are possible with respect to this collection but there is no dedicated legal framework that applies to it and therefore the resolution of social and ethical arising from its continued retention and future use require careful attention. Matters are complicated by the long-term nature of the collection - historically and into the future - whereby social attitudes and regulatory frameworks have changed over time and might change again in years to come. The prospect of the Guthrie collection being considered as a "de facto DNA database"⁵ means that these issues require on-going attention. Equally, as the transformative potential of biomedical collections grows at an exponential rate - bringing potential changes for health and well-being at the individual, local and global level through networked sharing of resources and data - the need to institute robust and flexible governance mechanisms has never been greater. These must perform the dual role of protecting the personal interests of people whose samples and data form the basis of the collection while also responsibly promoting legitimate uses of the collection as a valuable research resource that can realise the potential that they hold.

1.4 This report argues that a robust, flexible and adaptive system is required to govern the collection and deliver on these dual aims. This must remain fit-for-purpose over time and must strike a delicate balance between maximising the value of the collection as a public resource to be managed for the public good while minimising the risks to individuals whose samples and data are held as part of the collection. Evidence suggests that current practices could be improved towards an optimal governance system for the collection and which would strike the appropriate balance of interests. An important feature of this system would be its ability to engage with citizens on issues about how the resource in managed and run, including future dynamic ways that people can contribute to the resource and benefit from it.

1.5 The legal landscape is complicated because the collection contains both personal information and DNA samples and the law treats information and tissues differently. Nonetheless, there is evidence that the collection is treated as part of the health record in Scotland, making it subject primarily to data protection legislation; this is in keeping with recent human rights pronouncements about how DNA samples should be treated and suggests an obvious regulatory framework. A first question to address is the legal position with respect to the collection. Thereafter, even if it is the case that data protection is the primary legal concern, careful and sensitive exercises of judgment will have to made about granting access to, and allowing use of the resource. Governance arrangements must be robust and inspire confidence. Our work on public engagement has informed the recommendations on what good governance might look like in order to deliver these objectives.

1.6 The report details options for consideration as to how practices could be improved. In some cases it makes specific recommendations for action; in others, it identifies opportunities for future dialogue about this and other biomedical collections. It is argued that public engagement should be undertaken in the development, implementation and on-going operation of policies with respect to the collection and potential and future uses.

1.7 The remainder of this report is organised as follows:

Chapter 2 outlines current practice and the challenges associated with the collection, especially in light of recent experiences in other countries involving the management of similar collections.

Chapter 3 details that core considerations for this report, that is, the factors that must be taken into account in delivering an appropriate governance mechanism and when balancing the range of interests at stake.

Chapter 4 explores the legal basis for the collection

Chapter 5 examines issues related to consent and anonymisation

Chapter 6 is concerned with matters of storage and access

Chapter 7 addresses governance

Chapter 8 considers public attitudes and the role of public engagement in addressing the range of issues identified

Chapter 9 concludes with a summary of questions for consideration and offers recommendations on how various challenges could be met as well as opportunities for dialogue about the future direction of biomedical collections.