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    • Publisher:
      Cambridge University Press
      Publication date:
      09 June 2021
      24 June 2021
      ISBN:
      9781108620024
      9781108475976
      Creative Commons:
      Creative Common License - CC Creative Common License - BY Creative Common License - NC
      This content is Open Access and distributed under the terms of the Creative Commons Attribution licence CC-BY-NC 4.0.
      https://creativecommons.org/creativelicenses
      Dimensions:
      (253 x 177 mm)
      Weight & Pages:
      0.97kg, 436 Pages
      Dimensions:
      Weight & Pages:
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    Book description

    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.

    Reviews

    ‘This is an excellent book … I learned a great deal by reading it, gained much food for thought and know that I will return to it often, and hence I can highly recommend it.’

    Lyn Horn Source: Bioethics

    ‘a rigorously edited, multidisciplinary handbook that has it all: from a solid conceptual framework that comprehends the axiological foundations of health research to the corresponding regulatory and procedural safeguards for the subjects involved … This volume in the "Cambridge Handbook" series is the perfect tool for students of health research regulation; biomedical investigators, industry regulators, or those seeking justice before a court of law; and professionals charged with administering justice … Highly recommended.’

    P. Rodriguez del Pozo Source: Choice Connect

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    Contents

    Full book PDF

    Page 1 of 3


    • The Cambridge Handbook of Health Research Regulation
      pp i-ii
    • The Cambridge Handbook of Health Research Regulation - Title page
      pp iii-iii
    • Copyright page
      pp iv-iv
    • Dedication
      pp v-vi
    • Dedication
      pp v-vi
    • Contents
      pp vii-x
    • Contents
      pp vii-x
    • Figures
      pp xi-xii
    • Tables
      pp xiii-xiv
    • Contributors
      pp xv-xviii
    • Contributors
      pp xv-xviii
    • Acknowledgements
      pp xix-xx
    • Introduction
      pp 1-10
    • Towards a Learning Health Research Regulation System
    • Part I - Concepts, Tools, Processes
      pp 11-224
    • Section IA - Concepts
      pp 13-98
    • Introduction
    • 1 - Vulnerability
      pp 17-26
    • 2 - Autonomy
      pp 27-36
    • Relational Conceptions
    • 3 - Proportionality in Health Research Regulation
      pp 37-45
    • 4 - Social Value
      pp 46-55
    • 5 - Solidarity in Health Research Regulation
      pp 56-64
    • 6 - The Public Interest
      pp 65-72
    • 7 - Privacy
      pp 73-80
    • 8 - Trustworthy Institutions in Global Health Research Collaborations
      pp 81-89
    • 9 - Vulnerabilities and Power
      pp 90-98
    • The Political Side of Health Research
    • Section IB - Tools, Processes and Actors
      pp 99-102
    • Introduction
    • 10 - Consent
      pp 103-111
    • 11 - Forms of Engagement
      pp 112-120
    • 13 - Risk-Benefit Analysis
      pp 130-138

    Page 1 of 3


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