The Cambridge Handbook of Health Research Regulation

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