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Cambridge University Press
Online publication date:
June 2021
Print publication year:
Online ISBN:
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

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.


‘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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Full book PDF

Page 1 of 2

  • 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
  • Contents
    pp vii-x
  • Figures
    pp xi-xii
  • Tables
    pp xiii-xiv
  • 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
  • 15 - Benefit Sharing
    pp 148-157
  • From Compensation to Collaboration
  • 17 - Rules, Principles and the Added Value of Best Practice in Health Research Regulation
    pp 167-176

Page 1 of 2


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