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Publisher:
Cambridge University Press
Online publication date:
June 2021
Print publication year:
2021
Online ISBN:
9781108620024
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

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 2 of 2


  • 18 - Research Ethics Review
    pp 177-186
  • 19 - Data Access Governance
    pp 187-196
  • Part II - Reimagining Health Research Regulation
    pp 225-400
  • Section IIA - Private and Public Dimensions of Health Research Regulation
    pp 227-274
  • Introduction
  • 23 - Changing Identities in Disclosure of Research Findings
    pp 229-238
  • 25 - Mobilising Public Expertise in Health Research Regulation
    pp 248-256
  • Section IIB - Widening the Lens
    pp 275-332
  • Introduction
  • Section IIC - Towards Responsive Regulation
    pp 333-334
  • Introduction
  • 34 - Human Gene Editing
    pp 335-343
  • Traversing Normative Systems
  • 37 - When Is Human?
    pp 365-372
  • Rethinking the Fourteen-Day Rule
  • 38 - A Perfect Storm
    pp 373-381
  • Non-evidence-Based Medicine in the Fertility Clinic
  • 39 - Medical Devices Regulation
    pp 382-390
  • New Concepts and Perspectives Needed
  • Afterword
    pp 391-400
  • What Could a Learning Health Research Regulation System Look Like?
  • Index
    pp 401-422

Page 2 of 2


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