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Table of Contents
Preface; Contents; Chapter 1: Introduction; References; Part I: Introducing New Domains of Research Governance; Chapter 2: Should Research Ethics Encourage the Production of Cost-Effective Interventions?; 2.1 Introduction; 2.2 Cost-Effectiveness in the Development of New Interventions; 2.3 Why Promote Cost-Effective Interventions at the Research Stage?; 2.3.1 Appropriate Use of Scarce Resources; 2.3.2 Supporting Downstream Actors; 2.3.3 Social Value and Fairness to Research Subjects; 2.4 Objections to Considering Cost-Effectiveness at the Research Stage.
2.4.1 The Unpredictability of Effectiveness2.4.2 The Unpredictability of Cost; 2.4.3 Equity Concerns About Cost-Effectiveness Analysis; 2.4.4 Freedom of Intellectual Inquiry; 2.5 Who Should Ensure That Research Promotes the Development of Cost-Effective Interventions?; 2.5.1 Research Ethics Committees; 2.5.2 Research Advisory Committees; 2.5.3 Sponsors; 2.5.4 Investigators; 2.5.5 Research Subjects; 2.6 Conclusion; References; Chapter 3: From Altruists to Workers: What Claims Should Healthy Participants in Phase I Trials Have Against Trial Employers?; 3.1 Introduction.
3.2 Is Phase I Research a Form of Work?3.2.1 Earnings-Based Conception of Work; 3.2.2 Time-Based Conception of Work; 3.2.3 Meaning-Based Conception of Work; 3.2.4 The Relationship Between Earnings-Based, Time-Based, and Meaning-Based Conceptions of Work; 3.3 Potentially Problematic Aspects of Phase I Research Work; 3.3.1 Risk and Phase I Research Work; 3.3.2 Shifting Phase I Research Work's Occupational Bucket; 3.3.3 Occupational Flexibility/Authority and Phase I Research Work; 3.4 Two Implications for Research Ethics; 3.4.1 Payment Ceilings; 3.4.2 Trial Data Transparency; 3.5 Conclusion.
5.2.2 Research Requires Systematic Investigation5.2.3 Research Potentially Presents Less Net Clinical Benefit and Greater Overall Risk Than Clinical Practice; 5.2.3.1 Tailoring of Therapy; 5.2.3.2 Total Body Irradiation; 5.2.4 Research Introduces Burdens or Risks from Activities That Are Not Otherwise Part of Patient Care; 5.2.5 Research Uses Protocols to Dictate Which Therapeutic or Diagnostic Interventions a Patient Receives; 5.2.6 Summary; 5.3 Discussion; 5.4 Conclusion; References.
2.4.1 The Unpredictability of Effectiveness2.4.2 The Unpredictability of Cost; 2.4.3 Equity Concerns About Cost-Effectiveness Analysis; 2.4.4 Freedom of Intellectual Inquiry; 2.5 Who Should Ensure That Research Promotes the Development of Cost-Effective Interventions?; 2.5.1 Research Ethics Committees; 2.5.2 Research Advisory Committees; 2.5.3 Sponsors; 2.5.4 Investigators; 2.5.5 Research Subjects; 2.6 Conclusion; References; Chapter 3: From Altruists to Workers: What Claims Should Healthy Participants in Phase I Trials Have Against Trial Employers?; 3.1 Introduction.
3.2 Is Phase I Research a Form of Work?3.2.1 Earnings-Based Conception of Work; 3.2.2 Time-Based Conception of Work; 3.2.3 Meaning-Based Conception of Work; 3.2.4 The Relationship Between Earnings-Based, Time-Based, and Meaning-Based Conceptions of Work; 3.3 Potentially Problematic Aspects of Phase I Research Work; 3.3.1 Risk and Phase I Research Work; 3.3.2 Shifting Phase I Research Work's Occupational Bucket; 3.3.3 Occupational Flexibility/Authority and Phase I Research Work; 3.4 Two Implications for Research Ethics; 3.4.1 Payment Ceilings; 3.4.2 Trial Data Transparency; 3.5 Conclusion.
5.2.2 Research Requires Systematic Investigation5.2.3 Research Potentially Presents Less Net Clinical Benefit and Greater Overall Risk Than Clinical Practice; 5.2.3.1 Tailoring of Therapy; 5.2.3.2 Total Body Irradiation; 5.2.4 Research Introduces Burdens or Risks from Activities That Are Not Otherwise Part of Patient Care; 5.2.5 Research Uses Protocols to Dictate Which Therapeutic or Diagnostic Interventions a Patient Receives; 5.2.6 Summary; 5.3 Discussion; 5.4 Conclusion; References.