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Ethics and Governance of Biomedical Research

Theory and Practice

  • Book
  • © 2016

Overview

Editors:
  1. Daniel Strech

    1. Hannover Medical School, Institute for History, Ethics and Philos, Hannover, Germany

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    You can also search for this editor in PubMed   Google Scholar

  2. Marcel Mertz

    1. University Hospital Cologne, Research Unit Ethics, Institute for Hist, Cologne, Germany

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    You can also search for this editor in PubMed   Google Scholar

  • Discusses concrete,
  • empirically salient, and timely ethical issues in research governance
  • Provides case studies that vividly demonstrate the wide dimensions of
  • preclinical, clinical and public health research ethics
  • Contains contributions by authors from different nations guaranteeing international perspectives
  • Includes supplementary material: sn.pub/extras

Part of the book series: Research Ethics Forum (REFF, volume 4)

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Table of contents (16 chapters)

  1. Front Matter

    Pages i-viii
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  2. Introduction

    • Daniel Strech, Marcel Mertz
    Pages 1-10

  4. Challenges in Common Domains of Research Governance

    1. Front Matter

      Pages 57-57
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    2. Discriminating Between Research and Care in Paediatric Oncology—Ethical Appraisal of the ALL-10 and 11 Protocols of the Dutch Childhood Oncology Group (DCOG)

      • Sara A. S. Dekking, Rieke van der Graaf, Martine C. de Vries, Marc B. Bierings, Johannes J. M. van Delden
      Pages 59-72

    3. What Does the Child’s Assent to Research Participation Mean to Parents? Empirical Findings in Paediatric Oncology in Germany

      • Imme Petersen, Regine Kollek
      Pages 73-86

    4. Assent in Paediatric Research and Its Consequences

      • Jan Piasecki, Marcin Waligora, Vilius Dranseika
      Pages 87-95

    5. Ethical Principles in Phase IV Studies

      • Rosemarie D. L. C. Bernabe
      Pages 97-107

    6. Fate of Clinical Research Studies After Ethical Approval—Follow-Up of Study Protocols Until Publication

      • Anette Blümle, Joerg J. Meerpohl, Martin Schumacher, Erik von Elm
      Pages 109-123

    7. Do Editorial Policies Support Ethical Research? A Thematic Text Analysis of Author Instructions in Psychiatry Journals

      • Daniel Strech, Courtney Metz, Hannes Kahrass
      Pages 125-134

  5. Improving Common Domains of Research Governance

    1. Front Matter

      Pages 135-135
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    2. Ensemble Space and the Ethics of Clinical Development

      • Jonathan Kimmelman, Spencer Phillips Hey
      Pages 137-151

    3. Rethinking Risk–Benefit Evaluations in Biomedical Research

      • Annette Rid
      Pages 153-162

    4. Towards an Alternative Account for Defining Acceptable Risk in Non-beneficial Paediatric Research

      • Sapfo Lignou
      Pages 163-173

    5. Big Biobanks: Three Major Governance Challenges and Some Mini-constitutional Responses

      • Roger Brownsword
      Pages 175-196

    6. Ethical Dimensions of Dynamic Consent in Data-Intense Biomedical Research—Paradigm Shift, or Red Herring?

      • Bettina Schmietow
      Pages 197-209

    7. Using Patent Law to Enforce Ethical Standards: Proposal of a New Patent Requirement

      • Jan-Ole Reichardt
      Pages 211-225
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Keywords

About this book

In this book, scholars with different disciplinary and national backgrounds argue for possible answers and analyse case studies on current issues of governance in biomedical research. These issues comprise among others the research-care distinction, risk evaluation in early human trials, handling of incidental findings, nocebo effects, cluster randomized trials, publication bias, or consent in biobank research. This book demonstrates how new technologies and research possibilities multiply or intensify already known governance challenges, leaving room for ethical analysis and complex moral choices. Clinical researchers, research ethics committee members and research ethicists have all to deal with such challenges on a daily basis. While general reflection on core concepts of research ethics is seldom pointless, those confronted with hard moral choices do need more practical and contextualized reflection on the said issues. This book particularly provides such contextualized reflectionsand aims to inform all those who study, conduct, regulate, fund, or participate in biomedical research.

Editors and Affiliations

  • Hannover Medical School, Institute for History, Ethics and Philos, Hannover, Germany

    Daniel Strech

  • University Hospital Cologne, Research Unit Ethics, Institute for Hist, Cologne, Germany

    Marcel Mertz

About the editors



Bibliographic Information

  • Book Title: Ethics and Governance of Biomedical Research

  • Book Subtitle: Theory and Practice

  • Editors: Daniel Strech, Marcel Mertz

  • Series Title: Research Ethics Forum

  • DOI: https://doi.org/10.1007/978-3-319-28731-7

  • Publisher: Springer Cham

  • eBook Packages: Religion and Philosophy, Philosophy and Religion (R0)

  • Copyright Information: Springer International Publishing Switzerland 2016

  • Hardcover ISBN: 978-3-319-28729-4Published: 17 May 2016

  • Softcover ISBN: 978-3-319-80412-5Published: 27 May 2018

  • eBook ISBN: 978-3-319-28731-7Published: 09 May 2016

  • Series ISSN: 2212-9529

  • Series E-ISSN: 2212-9537

  • Edition Number: 1

  • Number of Pages: VIII, 225

  • Number of Illustrations: 1 b/w illustrations, 6 illustrations in colour

  • Topics: Ethics, Theory of Medicine/Bioethics, Medical Law

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