Beruflich Dokumente
Kultur Dokumente
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Table of Contents
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Volume One: Report
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Summary and Conclusions 1
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Part I: How Did This Issue Arise? 7
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Part II: Do Deserving Subjects Not Receive
Compensation? 47
A Question of Justice 50
The Argument from Fairness 50
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The Gift of Security: Consenting Subjects as Free
Agents 53
Fairness vs. Consent 56
Additional Reasons for Compensation 60
Appropriate Regard for Patient-Subjects'
Well-Being. .- 60
Public Conceptions of Justice 61
Obligations to Subjects in Therapeutic Reseatch 61
Conclusions 63
Chapter 4: The Nature and Extent of Research-Related
Injuries 65
Longitudinal Institutional Studies 67
General Research Program: University of
Washington. Seattle 67
Nontherapeutic and Therapeutic Drug Testing:
Quincy Research Center 69
Nontherapeutic Drug Testing: Michigan State
Prison 71
Broadly Based Sources of Data 71
Government-Reported Incidence of Harm 72
Prospective Approach 73
Number of subjects 74
Subject characteristics 74
Risks of research 77
Conclusions 79
Chapter 5: Existing Remedies and Their Limitations 81
Negligence 83
Requirements for. and Obs.tacles to, Recovery 84
Critique of Negligence as a Remedial Mechanism 88
Strict Liability 90
Roots in History and Policy 90
Applicability to Research Injuries 91
Critique of Strict Liability 95
Nonfault Approaches 97
Government Compensation Programs 97
Insurance Mechanisms 98
Table
Table 1. Demographic Characteristics of
Biomedical and Behavioral
Research Subjects 75
Figures
Figure 1. Subjects Participating in Research
(By Percent of Projects) 76
Figure 2. Distribution of Therapeutic/
Nontherapeutic Projects (By Type of
Institution) 77
Figure 3. Percent of All Subjects Exposed to Four
Invasive Procedures Most Frequently
Used in Research 78