The Cambridge Handbook of Health Research Regulation (Cambridge Law Handbooks)

The first ever interdisciplinary handbook in the field, this vital resource offers wide-ranging analysis of health research regulation. The chapters confront gaps between documented law and research in practice, and draw on legal, ethical and social theories about what counts as robust research regulation to make recommendations for future directions. The Handbook provides an account and analysis of current regulatory tools - such as consent to participation in research and the anonymization of data to protection participants' privacy - as well as commentary on the roles of the actors and stakeholders who are involved in human health research and its regulation. Drawing on a range of international examples of research using patient data, tissue and other human materials, the collective contribution of the volume is to explore current challenges in delivering good medical research for the public good and to provide insights on how to design better regulatory approaches. This title is also available as Open Access on Cambridge Core. Cover Half-title Title page Copyright information Dedication Contents List of Figures List of Tables List of Contributors Acknowledgements Introduction: Towards a Learning Health Research Regulation System 1 Introduction 2 What Is Health Research Regulation and What Is the Problem? 3 How Has the Health Research Regulation Landscape Been Changing (and What Are We Prepared to Do about It)? 4 The Dynamic Contours of Research and the Challenges of Regulatory Catch-up 5 Navigating the Cambridge Handbook of Health Research Regulation Part I Concepts, Tools, Processes Section IA Concepts: Introduction 1 Vulnerability 1.1 Introduction 1.2 Vulnerability in Research Ethics Guidelines 1.3 Vulnerability: An Ambiguous Concept in HRR 1.4 Problems with the Labelling Approach to Vulnerability in Research 1.5 Analytic Approaches to Defining Vulnerability 1.6 What Work Can the Concept of Vulnerability Do? 1.7 Conclusion 2 Autonomy: Relational Conceptions 2.1 Introduction 2.2 Autonomy in Health Research Ethics Guidelines 2.3 The Individualistic Conception of Autonomy 2.4 Relational Autonomy 2.5 Relational Autonomy and Vulnerability 2.6 Relational Autonomy and Informed Consent 2.7 Conclusion 3 Proportionality in Health Research Regulation 3.1 Introduction 3.2 What Is Proportionality? 3.3 Proportionality of Review and Proportionality of Harms 3.4 The Challenge of Social Value 3.5 Complexities of Analysis 3.6 Procedural Approaches to Proportionality Assessments 3.7 Conclusion 4 Social Value 4.1 Introduction 4.2 Social Value in the 2016 CIOMS Guidelines 4.3 Social Value as Indication for a Change in Sociology of Science 4.4 Meaning of Social Value 4.5 Social Value in Scholarly Debate 4.6 Application 4.6.1 Benefit Analysis 4.6.2 Benefit Evaluation 4.6.3 Benefit Treatment 4.6.4 Decision-Making 4.7 Conclusion 5 Solidarity in Health Research Regulation 5.1 Introduction 5.2 The Meaning of Solidarity 5.3 The Three Tiers of Solidarity: Applicability and Adjustments in the Context of Health Research Regulation 5.4 Solidarity in Health Research Regulation 5.5 Solidarity in Research on Rare Diseases and Orphan Drugs 5.6 Conclusion Acknowledgements 6 The Public Interest 6.1 Introduction 6.2 The Public Interest: A Contested Concept 6.3 Appeals to the Public Interest in HRR 6.4 The Public Interest as Legal Device 6.5 The Public Interest as the Views of Actual Publics 6.6 The Public Interest: A Holistic Concept 6.7 Concluding Remarks 7 Privacy 7.1 Introduction: The Modern Difficulty 7.2 Privacy as a Normative Difficulty 7.3 Privacy as a Human Right 7.4 Privacy in Specific Legal Responses: Personal Data Protection and Informed Consent 7.5 Realising Privacy in Modern Research Governance 7.6 Conclusion 8 Trustworthy Institutions in Global Health Research Collaborations 8.1 Introduction 8.2 What Is a Collaboration? 8.3 Trust and Trustworthiness 8.4 Trust in Global Health Research 8.5 Trustworthy Institutions 8.6 Trustworthiness in Data Sharing Collaborations 8.7 Conclusion 9 Vulnerabilities and Power: The Political Side of Health Research 9.1 Introduction 9.2 Setting the Scene 9.3 Individuals' Vulnerability in Research 9.4 Individuals and Groups 9.5 Group Membership and Group Vulnerabilities 9.6 Politics and Protection 9.7 Conclusion Section IB Tools, Processes and Actors: Introduction 10 Consent 10.1 Introduction 10.2 The Changing Nature of Research 10.3 The Basis for Informed Consent 10.4 Legal Requirements for Informed Consent 10.5 The Limitations of Consent 10.6 New Digital Consent Mechanisms 10.7 Conclusion 11 Forms of Engagement 11.1 Introduction 11.2 Engaging with Critique 11.3 Forms of Public Engagement 11.4 Types of Publics 11.5 Public Engagement in Data Intensive Health Research: Principles for an Inclusive Approach 11.6 Conclusion 12 Participatory Governance in Health Research: Patients and Publics as Stewards of Health Research Systems 12.1 Introduction 12.2 Patient and Public Engagement in Health Research 12.3 Participatory Governance in Health Research Systems 12.4 Enabling Conditions and Institutional Designs 12.4.1 Enabling Conditions: Power/Resource Imbalances and Representativeness 12.4.2 Institutional Designs: Relationships, Trust and Leadership Support 12.5 Conclusion 13 Risk-Benefit Analysis 13.1 Introduction 13.2 Identifying Risks 13.3 Identifying Benefits 13.4 Quantifying Risks and Benefits 13.5 Weighing Risks and Benefits 13.6 Procedural Issues in Risk-Benefit Analysis 13.7 Conclusion 14 The Regulatory Role of Patents in Innovative Health Research and Its Translation from the Laboratory to the Clinic 14.1 Introduction 14.2 Patents as a Form of Private Regulation 14.3 Use of Patent Rights in Innovative Health Research and Translation 14.4 Scope for Government Intervention 14.5 Emergent Self-Regulatory Models for Use of Patent Rights in Innovative Health Research and Translation 14.5.1 Non-exclusive Research Tool Licensing 14.5.2 Mixed Licensing Models 14.5.3 Collaborative Licensing 14.5.4 Ethical Licensing 14.6 Conclusion Acknowledgements 15 Benefit Sharing: From Compensation to Collaboration 15.1 Introduction 15.2 History and Rationale of Benefit Sharing 15.3 Regulation and Governance Frameworks 15.4. What, When and How: The Practicalities of Benefit Sharing 15.5 Worries and Future Challenges 15.6 Conclusion 16 Taking Failure Seriously: Health Research Regulation for Medical Devices, Technological Risk and Preventing Future Harm 16.1 Introduction 16.2 Expectations and Failure in Health Research 16.3 Using Failure to Address the Systemic Causes of Harm 16.4 Conclusion 17 Rules, Principles and the Added Value of Best Practice in Health Research Regulation 17.1 Introduction 17.2 The Significance of Regulatory Approaches 17.3 Rules and Principles-Based Approaches 17.4 Rules and Principles: Necessary but Not Sufficient 17.5 Supplementary Guidance and the Added Value of Best Practice 17.6 Conclusion 18 Research Ethics Review 18.1 Introduction 18.2 Research Ethics Review as a Regulatory Process 18.3 REC Criticisms: Poor Design and Performance and the Fetishisation of Consent 18.3.1 Poor Design and Performance 18.3.2 The Fetishisation of Consent 18.4 Future Directions for Research Ethics Review 18.4.1 Future Directions for Regulatory Design 18.4.2 Future Directions for Researching Research Ethics Review 18.5 Conclusion 19 Data Access Governance 19.1 Introduction 19.2 Goals of Data Access Governance 19.2.1 Protecting Data Subject Rights and Interests and Promoting Research Integrity and Ethics 19.2.2 Data Producer Rights and Interests 19.3 Data Access Governance: Policies, Processes, Agreements and Oversight 19.3.1 Controlled Versus Open Access Data 19.3.2 Data Access Agreements 19.3.3 Monitoring of Data Use 19.3.4 Maintaining Transparency 19.4 Best Practice Examples 19.4.1 Multi-study Access: European Genome-Phenome Archive (EGA) 19.4.2 Centralised Access: Database of Genotypes and Phenotypes (dbGaP) 19.4.3 Tiered Access: International Cancer Genome Consortium/25K Initiative 19.4.4 Independent, Interdisciplinary Access Involving Stakeholder Participation in Decisions: METADAC (Managing Ethical, Socio-Technical and Administrative Issues in Data Access) 19.4.5 Data Producers' Rights and Interests: ClinicalStudyDataRequest 19.4.6 Transparency and Reflexive Governance: UK Biobank (Ethics and Governance Framework) 19.5 Challenges and Future Directions 19.5.1 Resources, Effectiveness and Efficiency of Data Access Governance 19.5.2 Coordination between Oversight Bodies 19.5.3 Harmonisation of Access Policies and Processes 19.6 Conclusion 20 Is the Red Queen Sitting on the Throne?: Current Trends and Future Developments in Human Health Research Regulation 20.1 Introduction 20.2 Adaptation to the Environment: The Changing Research Landscape 20.3 Supporting Socially Valuable Research and the Role of Risk 20.4 Responding to Criticism and Supporting Research: Simplifying and Harmonising Processes 20.5 Countervailing Trends 20.6 Conclusion: A Parting Call for the Evaluation of Regulatory Changes 21 Regulatory Authorities and Decision-Making in Health Research: The Institutional Dimension 21.1 Introduction 21.2 Background: Defining Institutions and Institutional Contexts 21.3 Institutional Factors and Decision-Making: A Template of Influences 21.3.1 Central Objectives of the Decision-Making Body 21.3.2 Institutional Structure, Role and Composition of the Decision-Making Body and Overarching Institution 21.3.3 Path Dependencies and Historical Influences 21.3.4 Inter-institutional Influences 21.4 Conclusion 22 The Once and Future Role of Policy Advice for Health Regulation by Experts and Advisory Committees 22.1 Introduction 22.2 The Role of Evidence and Evidence Gathering to Inform Policy 22.3 Learned and Academic Societies as Experts for Government 22.4 The Role of Bioethics Advisory Committees 22.5 The Future of Advising on Health Research Regulation in a Liminal World Part II Reimagining Health Research Regulation Section IIA Private and Public Dimensions of Health Research Regulation: Introduction 23 Changing Identities in Disclosure of Research Findings 23.1 Introduction 23.2 Features of Existing Disclosure Guidance 23.3 The Changing Health Research Landscape 23.4 Re-focusing on Participants' Interests 23.5 A Wider Conception of Value: Research Findings as Narrative Tools 23.6 Revisiting Ethical Responsibilities for Feeding Back Findings 23.7 Conclusion 24 Health Research and Privacy through the Lens of Public Interest: A Monocle for the Myopic? 24.1 Introduction 24.2 Common Interests, Public Interest and Legitimacy 24.3 Common Interests in (Group) Privacy 24.4 Group Privacy Interests and the Law 24.4.1 Data Protection Law 24.4.2 Duty of Confidence 24.5 Conclusion 25 Mobilising Public Expertise in Health Research Regulation 25.1 Introduction 25.2 Trustworthiness of Research Governance 25.3 Patients or Public? Conceptualising What Interests Are Important 25.4 Conceptualising Public Expertise: Representation and Inclusiveness 25.5 Mobilising Public Expertise in Deliberation 25.6 Conclusion 26 Towards Adaptive Governance in Big Data Health Research: Implementing Regulatory Principles 26.1 Introduction 26.2 The Case for Adaptive Principles of Governance in Big Data Research 26.3 A Framework to Develop Systemic Oversight 26.4 Big Data Health Research: Implementing Effective Governance 26.5 Key Features of Governance Structures and Processes 26.6 Conclusion 27 Regulating Automated Healthcare and Research Technologies: First Do No Harm (to the Commons) 27.1 Introduction 27.2 NIPT, Genome-Editing and the Balancing of Interests 27.3 The Bigger Picture of Regulatory Responsibilities 27.3.1 The Bigger Picture 27.3.2 First-Tier Responsibilities 27.3.3 Second-Tier Responsibilities 27.4 Automated Healthcare and the Bigger Picture of Regulatory Responsibility 27.4.1 The Existence Conditions 27.4.2 The Conditions for Self-Development and Agency 27.4.3 The Conditions for Moral Development and Moral Agency 27.5 Conclusion Section IIB Widening the Lens: Introduction 28 When Learning Is Continuous: Bridging the Research-Therapy Divide in the Regulatory Governance of Artificial Intelligence as Medical Devices 28.1 Introduction 28.2 AI/ML Software as Clinical Decision Support 28.3 Re-embedding Risk and a Return to Sociality 28.4 Regulatory Governance as Participatory Learning System 28.5 Conclusion 29 The Oversight of Clinical Innovation in a Medical Marketplace 29.1 Introduction 29.2 Clinical Innovation and Its Oversight 29.3 The Case of Autologous Mesenchymal Stem Cell Interventions 29.4 Implications for Oversight of Clinical Innovation 29.5 Conclusion 30 The Challenge of 'Evidence': Research and Regulation of Traditional and Non-Conventional Medicines 30.1 Introduction 30.2 Background 30.3 Evidence-Based Medicine and Placebo Controls 30.4 Integration as Subordination: Guidelines and Regulations on Evidence and Research Methodologies 30.5 Beyond Evidence: The Economic Reasoning of Clinical Guidelines 30.6 Regulating for Uncertainty: Messy Knowledges and Practices 30.7 Conclusion 31 Experiences of Ethics, Governance and Scientific Practice in Neuroscience Research 31.1 Introduction 31.2 Negotiating the Ethical Dimensions of Neuroscience 31.3 Incidental Findings within Neuroimaging Research 31.4 Normative Uncertainties in Neuroscience 31.5 Discussion 31.6 Conclusion 32 Humanitarian Research: Ethical Considerations in Conducting Research during Global Health Emergencies 32.1 Introduction 32.2 The Context of Global Health Emergency Research 32.3 Justifying Research: Why, Where and When? 32.4 Justifying Research: What and How? 32.5 Governance and Oversight: Guidelines and Practices 32.6 New Orientations and Lenses 32.7 Conclusion 33 A Governance Framework for Advanced Therapies in Argentina: Regenerative Medicine, Advanced Therapies, Foresight, Regulation and Governance 33.1 Introduction 33.2 The Evolution of Regulation of Biotechnology in Argentina: Agricultural Strength and Human Health Fragmentation 33.3 First Steps in the Creation of A Governance Framework for Cell Therapies 33.4 From Transplants to Medicines 33.5 Key Drivers for the Construction of the Governance Framework 33.6 Current Legal/Regulatory Framework 33.7 Conclusion Section IIC Towards Responsive Regulation: Introduction 34 Human Gene Editing: Traversing Normative Systems 34.1 Introduction 34.2 Navigating Normative Systems for HGE 34.2.1 National Policy Frameworks 34.2.2 International Policy Frameworks 34.3 The Road to Harmonisation 34.4 Conclusion 35 Towards a Global Germline Ethics?: Human Heritable Genetic Modification and the Future of Health Research Regulation 35.1 Introduction 35.2 Germline Technologies: A Brief Overview 35.3 What Are We Regulating? What Should We Regulate? 35.4 Research or Reproduction? The Importance of Context 35.5 Regulation, Responsibility and Cooperative Practice 35.6 Global Regulation and Scientific Justice 35.7 Conclusion: Where Next for Global Germline Regulation? 36 Cells, Animals and Human Subjects: Regulating Interspecies Biomedical Research 36.1 Introduction 36.2 From Dish to Animal Host 36.3 Animals Containing Human Material 36.4 Assessing 'Human Contributions' to Experimental Animals 36.5 Shifting Regulatory Boundaries between Cells, Human Subjects and Experimental Animals 36.6 Conclusion: Realigning Human and Animal Vulnerabilities 37 When Is Human?: Rethinking the Fourteen-Day Rule 37.1 Introduction 37.2 Behind the Fourteen-Day Rule: The Warnock Report, and a 'Special Status' 37.3 Beyond fourteen days? 37.4 Revisiting the Rule 37.5 Conclusion 38 A Perfect Storm: Non-evidence-Based Medicine in the Fertility Clinic 38.1 Introduction 38.2 A Perfect Storm? 38.3 Regulating Add-On Services 38.4 Won't Patients Go Elsewhere? 38.5 Conclusion 39 Medical Devices Regulation: New Concepts and Perspectives Needed 39.1 Introduction 39.2 Enhancing Innovations 39.3 Core Concepts Implicated by the New Human Assemblage 39.4 Core Concepts and Medical Device Regulation 39.5 Conclusions Afterword: What Could a Learning Health Research Regulation System Look Like? 1 Introduction 2 Lessons from Learning Healthcare Systems and Regulatory Science 3 From Value to Values 4 Who is Implicated in this Ecosystem, and With Which Consequences? 5 What Could a Learning Health Research Regulation System Look Like? 6 Conclusion Index "The first ever interdisciplinary handbook in the field, this vital resource offers wide-ranging analysis of health research regulation. The chapters confront gaps between documented law and research in practice, and draw on legal, ethical and social theories about what counts as robust research regulation to make recommendations for future directions. The handbook provides an account and analysis of current regulatory tools - such as consent to participation in research and the anonymisation of data to protection participants' privacy - as well as commentary on the roles of the actors and stakeholders who are involved in human health research and its regulation. Drawing on a range of international examples of research using patient data, tissue and other human materials, the collective contribution of the volume is to explore current challenges in delivering good medical research for the public good and to provide insights on how to design better regulatory approaches. This title is also available as Open Access on Cambridge Core"-- Provided by publisher.