Informed Consent in Predictive Genetic Testing : A Revised Model

This important book proposes revising the current informed consent protocol for predictive genetic testing to reflect the trend toward patient-centered medicine. Emphasizing the predictive aspect of testing, the author analyzes the state of informed consent procedure in terms of three components: comprehension of risk assessment, disclosure to select appropriate treatment, and voluntariness. The book's revised model revisits these cornerstones, restructuring the consent process to allow for expanded comprehension time, enhanced patient safety, greater patient involvement and autonomy, and reduced chance of coercion by family or others. A comparison of the current and revised versions and case studies showing the new model in real-world applications add extra usefulness to this resource. Included in the coverage: * The science behind PGT. * Understanding genetic risks and probability. * The history of informed consent. * Revised model of informed consent: comprehension, disclosure, voluntariness, patient safety. * Applications of the model in DTC and pleiotropic genetic testing. * Implementation of the revised model, and assessing its effectiveness. A milestone in the bioethics literature, __Informed Consent in Predictive Genetic Testing__ will be of considerable interest to genetic counselors, medical and bioethicists, and public health professionals. Preface 5 Contents 7 Chapter-1 8 Introduction 8 A. Chapter 2: Predictive Genetic Testing 12 1. Science Behind PGT 12 2. Understanding Genetic Risks and Probabilities 12 3. Treatment Options 13 4. Family-Related Genetic Information 13 B. Chapter 3: History and Components of Informed Consent 14 1. Background of Informed Consent 14 2. Emergence of Components of Informed Consent 15 a. Comprehension 15 b. Disclosure 16 c. Voluntariness 16 C. Chapter 4: Revised Model of Informed Consent 17 1. Comprehension 17 2. Disclosure 18 3. Voluntariness 19 4. Patient Safety 19 D. Chapter 5: Application 20 1. DTC Genetic Testing 20 a. Background of DTC Genetic Testing 20 b. Application of the Revised Model 21 2. Pleiotropic Genetic Testing 23 a. Background of Pleiotropic Genetic Testing 23 b. Application of the Revised Model 23 E. Chapter 6: Conclusion 25 References 26 Chapter-2 28 Predictive Genetic Testing 28 A. The Science Behind PGT 29 1. Science 30 2. Utility 33 3. Benefits 34 4. Risks 35 B. Understanding Genetic Risks and Probabilities 38 1. Interpreting Test Results 38 2. Misunderstandings 40 3. Education 45 C. Treatment Options for Diagnosed Genetic Traits 46 1. Disclosure 46 2. Treatment Options 47 3. Hereditary Breast and Ovarian Cancer 48 D. Family-Related Genetic Information 50 1. Communication Patterns 51 2. Disclosure & Non-Disclosure of Test Results to Relatives 53 3. Genetic Exceptionalism 55 4. Coercion 57 E. Conclusion 58 References 61 Chapter-3 64 The History and Components of Informed Consent 64 A. The Background of Informed Consent 65 1. Clinical History 65 a. Early History 66 b. Mid 1900s 68 c. Late 1900s to early 2000 70 2. Research History 72 a. Early History 72 b. Mid 1900s 75 c. Late 1900s to early 2000 78 3. Conclusion 82 B. Emergence of the Components of Informed Consent 83 1. Comprehension 84 a. History 84 b. Autonomy 86 c. Competence 89 d. Understanding 92 2. Disclosure 93 a. History 94 b. Standards of Disclosure 96 c. Information Disclosed 97 3. Voluntariness 100 a. History 100 b. Freedom of Choice 102 C. Conclusion 108 References 109 Chapter-4 115 Revised Model of Informed Consent 115 A. Comprehension of Risk Assessment 116 1. Current Model 116 a. Autonomy 116 b. Understanding Genetic Risks 119 c. Doctor-Patient Relationship 121 2. Revised Model 123 a. Autonomy 123 b. Understanding Genetic Risks 126 c. Doctor-Patient Relationship 129 B. Disclosure to Select an Appropriate Treatment Option 131 1. Current Model 131 a. Disclosure 132 b. Genetic Counseling 133 2. Revised Model 135 a. Disclosure 136 b. Genetic Counseling 139 C. Voluntariness 144 1. Current Model 145 a. Coercion 145 b. Family-Related Implications 148 2. Revised Model 149 a. Coercion 149 b. Family-Related Implications 152 D. Patient Safety 154 1. Current Model 154 2. Revised Model 154 a. Accountability 155 b. Transparency 156 c. Trust 158 d. Patient Safety Systems 160 E. Conclusion 161 References 164 Chapter-5 170 Application of the Revised Model 170 A. DTC Genetic Testing and Informed Consent 170 1. Background of DTC Genetic Testing 171 a. DTC Genetic Testing 171 b. Test Results 172 c. Risk/Benefit Analysis 174 2. Application of the Revised Model 177 a. Comprehension 177 b. Disclosure 179 c. Voluntariness 183 d. Patient Safety 185 3. Case Study 189 a. Josh 189 b. Application 190 B. Pleiotropic Genetic Testing and Informed Consent 193 1. Background of Pleiotropic Genetic Testing 193 a. Pleiotropic Genetic Testing 194 b. Examples of Pleiotropic Genes 196 c. Risk/Benefit Analysis 200 2. Application of the Revised Model 203 a. Comprehension 204 b. Disclosure 207 c. Voluntariness 211 d. Patient Safety 214 3. Case Study 217 a. Morgan 217 b. Application 218 C. Conclusion 221 References 221 Chapter-6 226 Conclusion 226 A. Implementation of the Revised Model of Informed Consent 226 1. Response to Failed Attempts at Reform 227 2. System Changes 227 3. Reimbursement Changes 228 4. Measuring the Effectiveness of Implementation 230 B. Comparison Comparison of the Current and Revised Models 231 1. Comprehension 231 2. Disclosure 231 3. Voluntariness 232 4. Patient Safety 232 C. Contribution and Future Research 233 References 234 Index 236 This Important Book Proposes Revising The Current Informed Consent Protocol For Predictive Genetic Testing To Reflect The Trend Toward Patient-centered Medicine. Emphasizing The Predictive Aspect Of Testing, The Author Analyzes The State Of Informed Consent Procedure In Terms Of Three Components: Comprehension Of Risk Assessment, Disclosure To Select Appropriate Treatment, And Voluntariness. The Book's Revised Model Revisits These Cornerstones, Restructuring The Consent Process To Allow For Expanded Comprehension Time, Enhanced Patient Safety, Greater Patient Involvement And Autonomy, And Reduced Chance Of Coercion By Family Or Others. A Comparison Of The Current And Revised Versions And Case Studies Showing The New Model In Real-world Applications Add Extra Usefulness To This Resource. Included In The Coverage: The Science Behind Pgt. Understanding Genetic Risks And Probability. The History Of Informed Consent. Revised Model Of Informed Consent: Comprehension, Disclosure, Voluntariness, Patient Safety. Applications Of The Model In Dtc And Pleiotropic Genetic Testing. Implementation Of The Revised Model, And Assessing Its Effectiveness. A Milestone In The Bioethics Literature, Informed Consent In Predictive Genetic Testing Will Be Of Considerable Interest To Genetic Counselors, Medical And Bioethicists, And Public Health Professionals. Introduction -- Predictive Genetic Testing -- The History And Components Of Informed Consent -- Revised Model Of Informed Consent -- Application Of The Revised Model -- Conclusion. Jessica Minor. Includes Bibliographical References And Index. Mode Of Access: World Wide Web. This important book proposes revising the current informed consent protocol for predictive genetic testing to reflect the trend toward patient-centered medicine. Emphasizing the predictive aspect of testing, the author analyzes the state of informed consent procedure in terms of three components: comprehension of risk assessment, disclosure to select appropriate treatment, and voluntariness. The book's revised model revisits these cornerstones, restructuring the consent process to allow for expanded comprehension time, enhanced patient safety, greater patient involvement and autonomy, and reduced chance of coercion by family or others. A comparison of the current and revised versions and case studies showing the new model in real-world applications add extra usefulness to this resource. Included in the coverage: The science behind PGT. Understanding genetic risks and probability. The history of informed consent. Revised model of informed consent: comprehension, disclosure, voluntariness, patient safety. Applications of the model in DTC and pleiotropic genetic testing. Implementation of the revised model, and assessing its effectiveness. A milestone in the bioethics literature, Informed Consent in Predictive Genetic Testing will be of considerable interest to genetic counselors, medical and bioethicists, and public health professionals. -- Back cover Front Matter....Pages i-vii Introduction....Pages 1-20 Predictive Genetic Testing....Pages 21-56 The History and Components of Informed Consent....Pages 57-107 Revised Model of Informed Consent....Pages 109-163 Application of the Revised Model....Pages 165-220 Conclusion....Pages 221-230 Back Matter....Pages 231-232