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A Contemporary History of the Origins and Development of UK Biobank 1998-2005

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A Contemporary History of the Origins and Development of UK Biobank 1998-2005 A contemporary history of the origins and development of UK Biobank 1998-2005 Mairi Anna Langan A dissertation submitted in partial fulfilment of the degree of PhD University of Glasgow MRC Social and Public Health Sciences Unit August, 2007 © Mairi Langan, 2007 1 Abstract Background This thesis examines the origins and early development of UK Biobank. This is a resource funded in 2002 by the Medical Research Council, the Wellcome Trust, the Department of Health and the Scottish Executive to gather genetic and lifestyle information from half a million participants aged 40-69 years old in the UK and monitor their health for up to thirty years in order to improve the prevention, diagnosis and treatment of major diseases. UK Biobank was set up following the completion of the Human Genome Project in 2001, and was one of many established at around the same time with the goal of translating the knowledge of the human genome sequence into practical benefits for human health. (National genetic databases were also set up or proposed in Iceland, Estonia, Latvia, Sweden, Singapore, Tonga, Spain, and the United States). They, and the Human Genome Project, had raised a number of important issues about access to and ownership of genetic information. Aims The original aim of my PhD was to examine lay and professional understandings and responses to Biobank in the light of this background. However, UK Biobank took longer than expected to reach the stage of data collection, in part because of negotiations about its organisational structure. The aim therefore changed to address the question of how and why was UK Biobank initially configured in the manner it was. Organisational structure UK Biobank was originally set up by the funders with a ‘hub’ and ‘spoke’ model, with calls for bids from UK Universities for a central ‘hub’ charged with financial management and overall control of data and samples, and ‘spokes’ who were responsible for recruitment and data collection through primary care. The selection of both was made through the procurement rules of the EU. The hub (Manchester), six regional spokes, and the CEO (from Oxford) were all appointed simultaneously in 2003 and subsequently a Board of Directors and a number of committees were appointed. The CEO resigned in late 2004, and a new CEO and Principal Investigator 2 was appointed in 2005, after which there were significant changes to the organisational structure. Methods I conducted 76 oral history interviews with academic scientists directly and indirectly involved in UK Biobank, representatives of all four funding bodies, and representatives of UK Biobank Limited (the company set up to manage UK Biobank). I also conducted archival analysis of the MRC’s official documents concerning the origins and development of UK Biobank. Findings From its beginning UK Biobank was marked by tension between academic scientists on the one hand and representatives of the funding bodies and UK Biobank Limited on the other. Academic scientists criticised the funding bodies for establishing UK Biobank in a way that departed from what I have termed ‘standard academic scientific practice’. Spokes felt they should receive some privileged access to data they would contribute to collecting, and felt that the set up did not recognise the performance indicators driving scientists and universities. Lack of clarity over who was in control of UK Biobank contributed to these tensions as both spokes and funders felt that the other exerted undue influence. Some mistrust developed between academic scientists and representatives of the funding bodies and UK Biobank Limited. Discussion The configuration of UK Biobank was difficult for academic scientists and representatives of both the funding bodies and UK Biobank alike. Organisational issues, typical of those confronting Big Science initiatives, were largely responsible for this difficult legacy. Issues of leadership, the hub and spoke model, the sequencing of funding decisions, appointment of groups and committees and protocol development, uncertainties about who was in control, and ambiguities within the organisational structure as a whole were the most significant issues in the origins and development of UK Biobank, as the organisational changes in 2005 testify. 3 Contents Abstract 1 Contents 3 List of Tables 8 Preface 9 Abbreviations 13 Declaration 15 Chapter One: Introduction and Literature Review 16 1.1 Background and Aim 16 1.1.1 ‘The UK Biobank gets funding go-ahead’ 16 1.1.2 The post-genome challenge and UK Biobank 17 1.1.3 Why a contemporary history? 18 1.1.4 Aim 19 1.2 The Human Genome Project 22 1.3 International Context 29 1.4 Description of UK Biobank 32 1.5 Literature Review 36 1.5.1 Historiography of Contemporary Science 37 1.5.1 (a) The history of contemporary science 37 1.5.1 (b) Relationship between historian and scientist 40 1.5.2 ‘Big Science’ 45 1.5.2 (a) The MRC AIDS Directed Programme 46 1.5.2 (b) CERN 48 1.5.2 (c) The Space Telescope 51 1.5.2 (d) The term ‘Big Science’ 54 1.5.2 (e) Characteristics of Big Science 56 1.5.2 (f) Criticisms 66 1.5.3 Concluding Remarks 68 1.6 Thesis Outline 70 Chapter Two: Methods 72 2.1 Introduction 72 2.2 Historical Theory 75 4 2.2.1 Oral History 76 2.2.2 Why oral history interviews and archival research? 81 2.3 Oral History Interviews 85 2.3.1 Sampling 85 2.3.2 Access 89 2.3.3 Response 90 2.3.4 Ethics 92 2.3.5 Confidentiality 92 2.3.6 Pilot Interviews 98 2.3.7 Schedule 99 2.3.8 Telephone Interviews 100 2.3.9 Researching Elites 101 2.4 Archival Research 108 3.4.1 Access 108 3.4.2 Confidentiality 110 3.4.3 Approach to the Documents 111 2.5 Analysis 114 2.5.1 Thematic Approach 114 2.5.2 Summaries 115 Chapter Three: Chronology 118 3.1 Introduction 118 3.2 Development of the proposal for UK Biobank (1998-2000) 121 3.2.1 MRC/Wellcome Trust Workshop (1998-1999) 121 3.2.2 Expert Working Group (1999-2000) 122 3.3 Protocol Development and Consultation (2001-2003) 125 3.3.1 Protocol Development Committee (2001) 125 3.3.2 International Peer Review of Draft Protocol (2001-2002) 127 3.3.3 Consultation (2001-2003) 129 3.4 Funding Decision (2002) 136 3.4.1 MRC Funding Decision (2002) 136 3.5 Internal Organisation in the Funding Bodies (2000-2003) 138 3.6 Implementation of the Organisational Structure (2003-2005) 141 3.6.1 The ‘hub’ and ‘spoke’ model (2002-2005) 142 3.6.1 (a) Hub and Spoke Selection (2002-2003) 142 3.6.1 (b) Implementation of the hub and spoke model (2003-2005) 145 3.6.2 Establishment of Committees (2003-2004) 146 3.7 Organisational Change (2004-2005) 151 5 3.7.1 Appointment of CEO and Principal Investigator (2005) 151 3.7.2 Organisational Changes (2005) 151 3.8 Key Observations 153 Chapter Four: Emergent Issues: Standard Academic Scientific Practice 156 4.1 Introduction 156 4.2 Protocol Development 158 4.2.1 The purpose of the protocol 158 4.2.2 Consultation undertaken in protocol development 160 4.3 Funding 164 4.3.1 The funding of UK Biobank 164 4.3.2 Calculation of the funding figure 165 4.3.3 Role of the funding bodies 166 4.4 Development of the Ethics and Governance Framework (EGF) 169 4.4.1 Support for EGF development in tandem with protocol development 169 4.4.2 Difficulties of EGF development in tandem with protocol development 170 4.5 Leadership 173 4.5.1 Lack of a Principal Investigator 173 4.5.2 Lack of a figurehead 174 4.5.3 Explanations for the perceived lack of leadership 175 4.6 Organisational Structure 176 4.6.1 Establishment of UK Biobank Limited 176 4.6.2 Spoke selection and establishment 178 4.6.3 Establishment of committees 181 4.6.4 Sequence of the establishment of UK Biobank 182 4.7 Organisational Changes 185 4.7.1 Organisational Changes as indicative of standard academic scientific practice 185 4.7.2 Comparison of the funding bodies’ and UK Biobank Limited’s perception of 186 the changes with that of spokes 4.8 Conclusion 188 Chapter Five: Emergent Issues: Control 190 5.1 Introduction 190 5.2 Protocol Development 191 5.2.1 Criticism of the consultation undertaken with the Protocol Development 191 Committee 5.2.2 Documentary evidence of criticism of the consultation undertaken with the 193 Protocol Development Committee 6 5.3 Funding Bodies 196 5.3.1 Criticism of the funding bodies’ role 196 5.3.2 Relative influence of the two main funding bodies 200 5.3.3 Funding bodies’ perceptions of their role 201 5.4 Leadership 205 5.4.1 Lack of a leader 205 5.4.2 Leadership by committee rather than by an individual 206 5.4.3 Academic scientific and managerial leadership 209 5.5 Organisational Structure 211 5.5.1 Establishment of the hub as a company 211 5.5.2 The ‘hub’ and ‘spoke’ model 212 5.5.3 Role of the hub and spokes 215 5.6 Organisational Changes 220 5.6.1 Organisational changes as resolution to confusion over control 220 5.6.2 Motivation for the organisational changes 222 5.7 Conclusion 224 Chapter Six: Emergent Issues: Trust 226 6.1 Introduction 226 6.2 Protocol Development 228 6.2.1 Initial and Ongoing protocol development 228 6.2.2 Development of Intensively Phenotyped Cohort (IPC) Proposal 231 6.3 Spoke members’ motivations for involvement 233 6.3.1 Spoke members’ motivations for involvement 233 6.3.2 Criticism of spoke members’ motivations for involvement 235 6.4 Organisational Structure 237 6.4.1 Lack of spoke payback 237 6.4.2 Confusion regarding spoke payback policy 241 6.4.3 Confusion over the bidding process 243 6.4.4 Confusion over the role of spokes 245 6.4.5 Confusion over the nature of UK Biobank Limited 249 6.5 Organisational Changes 251 6.5.1 Implementation of organisational
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