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Published online by Cambridge University Press:  09 June 2021

Graeme Laurie
University of Edinburgh
Edward Dove
University of Edinburgh
Agomoni Ganguli-Mitra
University of Edinburgh
Catriona McMillan
University of Edinburgh
Emily Postan
University of Edinburgh
Nayha Sethi
University of Edinburgh
Annie Sorbie
University of Edinburgh


Publisher: Cambridge University Press
Print publication year: 2021
Creative Commons
Creative Common License - CCCreative Common License - BYCreative Common License - NC
This content is Open Access and distributed under the terms of the Creative Commons Attribution licence CC-BY-NC 4.0


  1. List of Figures

  2. List of Tables

  3. List of Contributors

  4. Acknowledgements

  5. Introduction

    Graeme Laurie

  6. Part IConcepts, Tools, Processes

    1. Section IAConcepts

      1. Introduction

        Annie Sorbie

      2. 1Vulnerability

        Wendy A. Rogers

      3. 2Autonomy: Relational Conceptions

        Natalie Stoljar

      4. 3Proportionality in Health Research Regulation

        Owen Schaefer

      5. 4Social Value

        Johannes J. M. van Delden and Rieke van der Graaf

      6. 5Solidarity in Health Research Regulation

        Katharina Kieslich and Barbara Prainsack

      7. 6The Public Interest

        Annie Sorbie

      8. 7Privacy

        David Townend

      9. 8Trustworthy Institutions in Global Health Research Collaborations

        Angeliki Kerasidou

      10. 9Vulnerabilities and Power: The Political Side of Health Research

        Iain Brassington

    2. Section IBTools, Processes and Actors

      1. Introduction

        Edward Dove and Nayha Sethi

      2. 10Consent

        Jane Kaye and Megan Prictor

      3. 11Forms of Engagement

        Mhairi Aitken and Sarah Cunningham-Burley

      4. 12Participatory Governance in Health Research: Patients and Publics as Stewards of Health Research Systems

        Kim H. Chuong and Kieran C. O’Doherty

      5. 13Risk-Benefit Analysis

        Carl H. Coleman

      6. 14The Regulatory Role of Patents in Innovative Health Research and Its Translation from the Laboratory to the Clinic

        Dianne Nicol and Jane Nielsen

      7. 15Benefit Sharing: From Compensation to Collaboration

        Kadri Simm

      8. 16Taking Failure Seriously: Health Research Regulation for Medical Devices, Technological Risk and Preventing Future Harm

        Mark L. Flear

      9. 17Rules, Principles and the Added Value of Best Practice in Health Research Regulation

        Nayha Sethi

      10. 18Research Ethics Review

        Edward Dove

      11. 19Data Access Governance

        Mahsa Shabani, Adrian Thorogood and Madeleine Murtagh

      12. 20Is the Red Queen Sitting on the Throne? Current Trends and Future Developments in Human Health Research Regulation

        Stuart G. Nicholls

      13. 21Regulatory Authorities and Decision-Making in Health Research: The Institutional Dimension

        Aisling M. McMahon

      14. 22The Once and Future Role of Policy Advice for Health Regulation by Experts and Advisory Committees

        Eric M. Meslin

  7. Part IIReimagining Health Research Regulation

    1. Section IIAPrivate and Public Dimensions of Health Research Regulation

      1. Introduction

        Graeme Laurie

      2. 23Changing Identities in Disclosure of Research Findings

        Emily Postan

      3. 24Health Research and Privacy through the Lens of Public Interest: A Monocle for the Myopic?

        Mark Taylor and Tess Whitton

      4. 25Mobilising Public Expertise in Health Research Regulation

        Michael M. Burgess

      5. 26Towards Adaptive Governance in Big Data Health Research: Implementing Regulatory Principles

        Effy Vayena and Alessandro Blasimme

      6. 27Regulating Automated Healthcare and Research Technologies: First Do No Harm (to the Commons)

        Roger Brownsword

    2. Section IIBWidening the Lens

      1. Introduction

        Agomoni Ganguli-Mitra

      2. 28When Learning Is Continuous: Bridging the Research–Therapy Divide in the Regulatory Governance of Artificial Intelligence as Medical Devices

        Calvin W. L. Ho

      3. 29The Oversight of Clinical Innovation in a Medical Marketplace

        Wendy Lipworth, Miriam Wiersma, Narcyz Ghinea, Tereza Hendl, Ian Kerridge, Tamra Lysaght, Megan Munsie, Chris Rudge, Cameron Stewart and Catherine Waldby

      4. 30The Challenge of ‘Evidence’: Research and Regulation of Traditional and Non-Conventional Medicines

        Nayeli Urquiza Haas and Emilie Cloatre

      5. 31Experiences of Ethics, Governance and Scientific Practice in Neuroscience Research

        Martyn Pickersgill

      6. 32Humanitarian Research: Ethical Considerations in Conducting Research during Global Health Emergencies

        Agomoni Ganguli-Mitra and Matthew Hunt

      7. 33A Governance Framework for Advanced Therapies in Argentina: Regenerative Medicine, Advanced  Therapies, Foresight,  Regulation and Governance

        Fabiana Arzuaga

    3. Section IICTowards Responsive Regulation

      1. Introduction

        Catriona McMillan

      2. 34Human Gene Editing: Traversing Normative Systems

        Rosario Isasi

      3. 35Towards a Global Germline Ethics? Human Heritable Genetic Modification and the Future of Health Research Regulation

        Sarah Chan

      4. 36Cells, Animals and Human Subjects: Regulating Interspecies Biomedical Research

        Amy Hinterberger and Sara Bea

      5. 37When Is Human? Rethinking the Fourteen-Day Rule

        Catriona McMillan

      6. 38A Perfect Storm: Non-evidence-Based Medicine in the Fertility Clinic

        Emily Jackson

      7. 39Medical Devices Regulation: New Concepts and Perspectives Needed

        Shawn H. E. Harmon

      8. Afterword: What Could a Learning Health Research Regulation System Look Like?

        Graeme Laurie

  8. Index

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