Healthy volunteers in commercial clinical drug trials : when human beings become guinea pigs

This book provides a richly detailed contribution to the understanding of healthy volunteer experiences in clinical drug trials in the UK. Contemporary society, especially the West, has seen a significant increase in the production and use of pharmaceutical products, particularly for disease treatment. However, despite the large numbers of people involved, particularly in the UK, very little is known about their experiences in commercial phase I clinical drug trials. Shadreck Mwale critiques common conceptions of the terms 'volunteer' and 'altruism' as used in policy and practice of human involvement in clinical trials and calls for an awareness of the complexity of the terms and how the social contexts participants find themselves in shape acts of voluntarism. Based on extensive empirical evidence and conceptual analysis, the book presents new insights into the lives of healthy volunteers, challenges bioethical conceptions and generates new frameworks for policy and practice of FIHCTs. It will be of particular interest to scholars and practitioners in the wider social sciences, medical Sociology and medical anthropology, pharmacology and bioethics. Read more... Abstract: This book provides a richly detailed contribution to the understanding of healthy volunteer experiences in clinical drug trials in the UK. Contemporary society, especially the West, has seen a significant increase in the production and use of pharmaceutical products, particularly for disease treatment. However, despite the large numbers of people involved, particularly in the UK, very little is known about their experiences in commercial phase I clinical drug trials. Shadreck Mwale critiques common conceptions of the terms 'volunteer' and 'altruism' as used in policy and practice of human involvement in clinical trials and calls for an awareness of the complexity of the terms and how the social contexts participants find themselves in shape acts of voluntarism. Based on extensive empirical evidence and conceptual analysis, the book presents new insights into the lives of healthy volunteers, challenges bioethical conceptions and generates new frameworks for policy and practice of FIHCTs. It will be of particular interest to scholars and practitioners in the wider social sciences, medical Sociology and medical anthropology, pharmacology and bioethics Acknowledgements 6 Contents 8 Abbreviations 10 List of Tables 11 Introduction 12 Chapter 1 Healthy Volunteering and Phase I Clinical Drug Trials in the UK 17 Abstract 17 Beyond the Veil of Choice and Consent 17 What are Clinical Drug Trials? 19 Historical Context of Human Involvement in Clinical Drug Trials 20 History of Healthy Volunteering: The ‘Volunteering Turn’ 21 Conceptualising Volunteering 23 Incentives and Volunteering 27 Global Commercial and Political Context of Clinical Drug Trials 30 The Demographics of Healthy Volunteers 32 Summary 34 References 36 Chapter 2 Risk, Rewards, and Rational Consent in Healthy Volunteering 41 Abstract 41 Sociology and Rationality 41 Sociological Conceptions of Risk 44 Bioethics and the Logic of Human Involvement in Clinical Drug Trials 47 Rational Consent and Autonomy 48 Voluntarism 49 A Sociological Critique of the Two Principles of Bioethics 50 Payments and Voluntarism 50 Healthy Volunteering: An Economic Exchange and a Form of Labour 53 Healthy Volunteering as ‘Passive Labour’ 55 Summary 58 References 59 Chapter 3 Risk, Motivation and Decision-making in Everyday Life: A Phenomenological Approach 63 Abstract 63 Why a Phenomenological Approach? 63 Phenomenology: Motivation, Risk Perception, and Social Constraints 65 Topical Relevances 67 Interpretive Relevance 68 Motivational Relevance 68 The Individual and Structural Elements of Schutz’s System of Relevances 69 Summary 71 References 72 Chapter 4 Who Takes Part in Clinical Drug Trials? 74 Abstract 74 Significance of Healthy Volunteer Demographics in Clinical Drug Trials 74 The Survey Questionnaire 76 Findings 77 Gender and Age Demographics 77 Education 78 Employment: Income and Dependents 79 Nationalities and Ethnicities of Healthy Volunteers 81 Experience 82 Summary 83 References 85 Chapter 5 ‘Context Is Everything’: The Reality of Becoming a Human Guinea Pig 86 Abstract 86 Healthy Volunteer Motivations 86 Monetary Reward as Motivation 88 Becoming a Healthy Volunteer 90 Personal Debt Crises 90 Unemployment and Intermittent Work 91 Employed but Insufficient Income 91 How Did They Hear About Clinical Drug Trials? 92 Clinical Drug Trials Involvement as a Pragmatic Measure 93 Health Crisis in the Family and Heath Checks as Motivation 95 Biographical Situation 96 Summary 99 References 100 Chapter 6 Economic Exchanges? Healthy Volunteering as a Form of Labour 102 Abstract 102 Total Institution: Becoming ‘Valuable Data’ 103 Depersonalisation and Institutionalisation 103 Healthy Volunteer Redefined: Negotiating Personal Interest and Company Procedures 107 Market Exchange? 109 Healthy Volunteering as ‘Passive’ Labour 110 Bodies as ‘Resource’ 112 The Body and the ‘Price’ of Passive Labour in Clinical Drug Trials 114 Being a Vulnerable Research Subject 116 Summary 118 References 119 Chapter 7 Volunteering for Free Is Dead, Long Live Reciprocity? Revisiting the Gift Relationship 120 Abstract 120 The Gift Relationship Today 121 From Market Exchange to Reciprocal Relationship? 125 Healthy Volunteering: Moral Responsibility and Biological Citizenship 128 Moral Responsibility or Irresponsibility? 129 Biological Citizenship? 132 Summary 135 References 136 Chapter 8 When Human Beings Become Guinea Pigs 138 Abstract 138 Rational Consent, Trust, and Risk 138 The Volunteering Turn and Its Policy Implications 140 The Limits of Rational Consent 141 Motivations: Altruism or Economic Exchanges in Clinical Drug Trials? 142 Healthy Volunteering as ‘Passive Labour’ 144 Re-Reading Schutz: System of Relevances and Human Involvement in Commercial Phase I Clinical Drug Trials 145 Policy Implications: Improving Protection of Healthy Volunteers in Medical Research 150 References 153 References 155 Index 158 Front Matter ....Pages i-xix Healthy Volunteering and Phase I Clinical Drug Trials in the UK (Shadreck Mwale)....Pages 1-24 Risk, Rewards, and Rational Consent in Healthy Volunteering (Shadreck Mwale)....Pages 25-46 Risk, Motivation and Decision-making in Everyday Life: A Phenomenological Approach (Shadreck Mwale)....Pages 47-57 Who Takes Part in Clinical Drug Trials? (Shadreck Mwale)....Pages 59-70 ‘Context Is Everything’: The Reality of Becoming a Human Guinea Pig (Shadreck Mwale)....Pages 71-86 Economic Exchanges? Healthy Volunteering as a Form of Labour (Shadreck Mwale)....Pages 87-104 Volunteering for Free Is Dead, Long Live Reciprocity? Revisiting the Gift Relationship (Shadreck Mwale)....Pages 105-122 When Human Beings Become Guinea Pigs (Shadreck Mwale)....Pages 123-139 Back Matter ....Pages 141-150