Ethics and Governance of Biomedical Research

1. Introduction
Daniel Strech, Marcel Mertz

Part I. Introducing New Domains of Research Governance

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

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

4. Nocebo Effects: The Dilemma of Disclosing Adverse Events
Luana Colloca

Part II. Challenges in Common Domains of Research Governance

5. 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 Graaf, Martine C. Vries, Marc B. Bierings, Johannes J. M. Delden

6. What Does the Child’s Assent to Research Participation Mean to Parents? Empirical Findings in Paediatric Oncology in Germany
Imme Petersen, Regine Kollek

7. Assent in Paediatric Research and Its Consequences
Jan Piasecki, Marcin Waligora, Vilius Dranseika

8. Ethical Principles in Phase IV Studies
Rosemarie D. L. C. Bernabe

9. Fate of Clinical Research Studies After Ethical Approval—Follow-Up of Study Protocols Until Publication
Anette Blümle, Joerg J. Meerpohl, Martin Schumacher, Erik Elm

10. Do Editorial Policies Support Ethical Research? A Thematic Text Analysis of Author Instructions in Psychiatry Journals
Daniel Strech, Courtney Metz, Hannes Kahrass

Part III. Improving Common Domains of Research Governance

11. Ensemble Space and the Ethics of Clinical Development
Jonathan Kimmelman, Spencer Phillips Hey

12. Rethinking Risk–Benefit Evaluations in Biomedical Research
Annette Rid

13. Towards an Alternative Account for Defining Acceptable Risk in Non-beneficial Paediatric Research
Sapfo Lignou

14. Big Biobanks: Three Major Governance Challenges and Some Mini-constitutional Responses
Roger Brownsword

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

16. Using Patent Law to Enforce Ethical Standards: Proposal of a New Patent Requirement
Jan-Ole Reichardt

Keywords: Philosophy, Ethics, Theory of Medicine/Bioethics, Medical Law