Informed Consent: Legal Theory and Clinical Practice, Second Edition

Cover
......Page 1
Informed Consent
......Page 4
Copyright
......Page 5
Preface
......Page 8
Acknowledgments......Page 10
Contents......Page 12
Part I: An Introduction to Informed Consent......Page 14
1. Informed Consent: Framing the Questions......Page 16
The Clinical Setting......Page 17
The Idea of Informed Consent......Page 24
The Rules for Recovery......Page 25
References......Page 26
2. The Concept and Ethical Justification of Informed Consent......Page 27
What Is Informed Consent?......Page 28
Goals of Informed Consent......Page 31
Autonomy and Well-Being......Page 33
Ethical Justification of Informed Consent......Page 35
Constraints on Autonomy......Page 37
Diversity of Decision-Making Preferences......Page 39
Informed Consent: Right or Obligation......Page 43
Reconceptualizing Autonomy......Page 45
References......Page 48
Part II: The Legal Theory of Informed Consent......Page 52
The Historical Context......Page 54
The Transition from Simple to Informed Consent......Page 56
The Doctrine Defined......Page 57
Professional Standards......Page 59
Patient-Oriented Standards......Page 61
Mixed Standards......Page 64
Elements of Disclosure: Further Guidance for Physicians......Page 66
Nature of the Procedure......Page 67
Risks......Page 68
Alternatives or Options......Page 71
Benefits......Page 73
Physician-Specific Information......Page 74
Summary of the Requirements of Disclosure......Page 77
Understanding......Page 78
Voluntariness
......Page 80
References......Page 83
4. Exceptions to the Legal Requirements: Emergency, Waiver, Therapeutic Privilege, and Compulsory Treatment......Page 88
The Emergency Exception......Page 89
Effect of Invoking the Emergency Exception......Page 91
Therapeutic Privilege......Page 92
Judicial Formulations......Page 93
The Therapeutic Privilege in Perspective......Page 95
The Elements of Waiver......Page 98
The Issue of Voluntariness
......Page 100
The Waiver Exception in Perspective......Page 101
Compulsory Treatment......Page 103
References......Page 104
5. Exceptions to the Legal Requirements: Incompetence......Page 107
Global Versus Specific Incompetence......Page 109
Minors......Page 110
Standards for Determining Incompetence......Page 111
General Standards......Page 112
Specific Incompetence......Page 113
A Conjunctive Approach......Page 118
Who Makes the Determination?......Page 119
Choosing a Surrogate......Page 122
How Should the Surrogate Decide?......Page 125
The Role of the Courts......Page 130
The Advantages and Disadvantages of Judicial Review......Page 132
Ethics Committees......Page 134
Conclusion......Page 137
References......Page 138
6. Legal Rules for Recovery......Page 143
Theory of Recovery......Page 144
Negligence......Page 145
Battery Versus Negligence......Page 147
Causation......Page 149
Injury-Causation......Page 150
Decision-Causation......Page 151
Establishing Liability for Failure to ObtainInformed Consent......Page 153
References......Page 156
7. Critical Approaches to the Law of Informed Consent......Page 159
The Autonomy-Oriented Critique......Page 160
Proposed Changes in Legal Basis of Recovery......Page 162
Proposed Changes in the Focus of the Doctrine......Page 164
The Health-Oriented Critique......Page 165
Proponents of Strengthened Disclosure Requirements......Page 166
Proponents of Weakened Disclosure Requirements......Page 167
The Interactionist Critique......Page 170
A Synthetic Approach......Page 172
References......Page 174
Part III: The Clinical Setting......Page 178
Decision Making and Informed Consent:Event vs. Process......Page 180
Consent as an Event......Page 181
Consent as a Process......Page 184
Establishing the Relationship......Page 187
Defining the Problem......Page 189
Ascertaining the Goals of Treatment......Page 190
Selecting an Approach to Treatment......Page 192
Follow-up......Page 196
Conclusion......Page 198
References......Page 199
9. Consent Forms: Documentation and Guidance......Page 201
The Purposes and Effects of Consent Forms......Page 202
Confent......Page 207
Readability and Style
......Page 209
Manner and Means of Presentation......Page 212
Retention and Storage of Consent Documents......Page 214
The Legal Status of Consent Forms......Page 215
References......Page 218
10. Managed Care and Informed Consent......Page 221
What Is Managed Care?......Page 222
"Economic" Informed Consent......Page 225
Disclosure of Alternatives to "Authorized" Treatment......Page 230
An Approach to Informed Consent in an Eraof Managed Care......Page 234
References......Page 237
11. Patients Who Refuse Treatment......Page 240
Legal Attitudes Toward Refusal of Treatmentby Competent Patients......Page 241
Legal Attitudes Toward Refusal of Treatment on Behalfof Incompetent Patients......Page 244
The Dilemma of Refusal of Treatment in the
Clinical Setting......Page 246
Assessing Refusal of Treatment......Page 247
Responding to Refusal......Page 250
Informed Consent and Refusal of Treatment......Page 253
References......Page 255
Part IV: Consent to Research......Page 260
12. The Independent Evolution of Informed Consent to Research......Page 262
Current Regulation......Page 269
The Regulatory Approach......Page 271
Institutional Review Boards......Page 272
Exceptions......Page 274
Voluntariness, Understanding, and Competence......Page 278
Special Populations......Page 279
Prisoners......Page 280
Children......Page 282
Cognifively Impaired Subjects......Page 283
Socioeconomically or Educationally
Disadvantaged Persons......Page 284
Conclusion......Page 285
References......Page 287
Subject and Researcher—A Divergence of Interests......Page 292
Research and the Loss of Personal Care......Page 293
Divergence of Interests and Informed Consent to Research......Page 296
Investigators' Perspective......Page 297
The Structure of the Decisionmaking Process......Page 303
Content of Disclosure......Page 304
Disclosure as a Process......Page 308
Balancing fhe Costs and Benefits
......Page 310
References......Page 312
Part V: Advancing Informed Consent......Page 318
14. The Limits of Informed Consent......Page 320
Informed Consent and Autonomy in Nursing Homes......Page 321
The Cultural Context of Informed Consent......Page 324
Divergent Frameworks of Significance......Page 326
Emotional and Cognitive Preconceptions......Page 328
References......Page 330
15. An Agenda for the Future......Page 332
References......Page 337
A......Page 340
C......Page 341
D......Page 343
F......Page 344
I......Page 345
K......Page 346
M......Page 347
O......Page 348
P......Page 349
R......Page 350
S......Page 351
U......Page 352
W......Page 353