Ethics and Governance of Biomedical Research

1. Front Matter

   Pages i-viii

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2. Introduction

   • Daniel Strech, Marcel Mertz

   Pages 1-10

3. Introducing New Domains of Research Governance

   1. Front Matter

      Pages 11-11

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   2. Should Research Ethics Encourage the Production of Cost-Effective Interventions?

      • Govind Persad

      Pages 13-28

   3. From Altruists to Workers: What Claims Should Healthy Participants in Phase I Trials Have Against Trial Employers?

      • Rebecca A. Johnson

      Pages 29-45

   4. Nocebo Effects: The Dilemma of Disclosing Adverse Events

      • Luana Colloca

      Pages 47-55

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

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.

• clinical research
• cost-effective interventions
• medical law
• preclinical and clinical research
• preclinical research
• the nocebo effect

• 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

Policies and ethics