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Table of Contents
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Volume One: Report

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Summary and Conclusions 1

The Question at Issue 2


Alternative Responses to Inconclusive Data 2
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The Reconunended Experhnent 4


The Format of the Report 4

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Part I: How Did This Issue Arise? 7

Chapter 1: Introduction to the Social and Cultural


I Setting 9

Roles and Relationships in Human Experimentation 11


The Role of Biomedical and Behavioral Research 11
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The Role of the Research Subject 13


The Relationship of Subjects to the Research
Enterprise 15
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The Relationship of Subjects to the Beneficiaries


of Research 16
Risk (and Risk-Spreading) as a Social Problem 17
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Research Injuries and the Larger Social Context 19
The Basis for Public Policy 22
Social Responsibility and Individual Consent 22
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Administrative Practicability and the Plight of the
Helpless 22

Chapter 2: Historical Perspective 25


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Reliance on Codes and Consent (1945-1966) 25


Outside Encouragement for Self-Regulation 25
I Apparent Problems in a Mighty Enterprise 30
Prior Review and Limitations on Risk (1966-present) 33
Strengthening Regulations 35
I Continuing Reservations 39
The Study Undertaken by the President's Conunission 43

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Part II: Do Deserving Subjects Not Receive
Compensation? 47

Chapter 3: The Ethical Basis for Compensation 49


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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

Part III: What Should Be Done? 101


Chapter 6: Conduct an Experiment 103
Specific Aims of the Experiment 106
Research Plan 107
Methodological Issues 108
Sample Selection 108
Sample Size 110
Duration of Study 110
Costs 110
Standards for Evaluating the Desirability of Instituting
a Compensation Program 111
Chapter 7: Consider Various Features of Nonfault
Insurance PTograEns 113
Existing Governmental Programs as Models 114
F.E.C.A. and Other Workers' Compensation
Programs 115
Veterans Benefits 118
Vaccine and Immunization Programs 119
Evaluation of Governmental Alternatives 120
Insurance Mechanisms as Models 122
Institutional Private Insurance 122
Institutional Self-Insurance 123
Collective or Pooled Insurance 124
Evaluation of Insurance Alternatives 125
Objectives of a Compensation Program 126
Basic Elements of a Compensation Program 128
Variables to be Included in the Experimental Design 129
Scope of Covered Research 129
Government involvement 129
Type of research and IRB review 131
The problem of therapeutic research 132
Eligibility for Benefits 135
Subjects of covered research 135
Nontrivial bodily injuries 136
Causation 138
Standards of Conduct 139
Time for Making a Claim 140
Nature and Extent of Benefits 141
Limitations on Benefits 144
Pain and suffering 144
Punitive damages 145
Legal fees 145
Ceiling on Benefits 145
Offset for Recoveries from Collateral Sources 146
Relation to Alternative Legal Remedies 147
Resolution of Disputes 148
Financing Mechanisms 149

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

Volume Two: Appendices, which contains studies prepared for


the Commission, material submitted for its consideration, and
possible compensation plans, is available from the Superinten-
dent of Documents.