Ethics and Governance of Biomedical Research

Chapter 1 Introduction

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

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

Chapter 4 Nocebo Effects: The Dilemma of Disclosing Adverse Events

Chapter 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)

Chapter 6 What Does the Child’s Assent to Research Participation Mean to Parents? Empirical Findings in Paediatric Oncology in Germany

Chapter 7 Assent in Paediatric Research and Its Consequences

Chapter 8 Ethical Principles in Phase IV Studies

Chapter 9 Fate of Clinical Research Studies After Ethical Approval—Follow-Up of Study Protocols Until Publication

Chapter 10 Do Editorial Policies Support Ethical Research? A Thematic Text Analysis of Author Instructions in Psychiatry Journals

Chapter 11 Ensemble Space and the Ethics of Clinical Development

Chapter 12 Rethinking Risk–Benefit Evaluations in Biomedical Research

Chapter 13 Towards an Alternative Account for Defining Acceptable Risk in Non-beneficial Paediatric Research

Chapter 14 Big Biobanks: Three Major Governance Challenges and Some Mini-constitutional Responses

Chapter 16 Using Patent Law to Enforce Ethical Standards: Proposal of a New Patent Requirement