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Table of Contents
Intro; Dedication; Acknowledgements; Contents; Abbreviations; Chapter 1: Introduction; 1.1 Perinatal HIV Prevention Trials; 1.2 The SUPPORT Study; 1.3 Hospital Quality Improvement Research; 1.4 Henrietta Lacks; 1.5 The Facebook Study; 1.6 Overview of This Book; Chapter 2: Historical Background; 2.1 Research with Human Subjects Before World War II; 2.2 Research with Human Subjects During World War II; 2.3 Research with Human Subjects After World War II; 2.4 The Belmont Report; 2.5 The U.S. Federal Regulations; 2.6 Continuing Scandals and Controversies
2.7 Concerns About Integrity in Biomedical Research2.8 Jesse Gelsinger's Death; 2.9 Concerns About Research on Human Biosamples; 2.10 Conclusion: Human Research Regulations and Guidelines in Historical Context; Chapter 3: Moral Theory; 3.1 What Is a Moral Theory?; 3.2 Moral Subjectivism and Relativism; 3.3 Classifying Moral Theories; 3.4 Divine Command Theory; 3.5 Virtue Ethics; 3.6 Natural Law Theory; 3.7 Utilitarianism; 3.8 Kantianism; 3.9 Natural Rights Theories; 3.10 Pluralistic Theories; 3.11 Conclusion: Toward a Decision-Making Framework
Chapter 4: Trust as a Foundation for Research with Human Subjects4.1 What Is Trust?; 4.2 Trust in Research Involving Research with Human Subjects; 4.3 Trust as a Foundation for the Ethics of Research with Human Subjects: Some Alternative Views; 4.4 Trust as a Foundation for the Ethics of Research with Human Subjects: My View; 4.5 Promoting Trust in Research with Human Subjects; 4.6 The Relationship Between Moral Principles and Research Regulations and Guidelines; 4.7 The Role of Trust in Resolving Ethical Dilemmas in Research withHuman Subjects
4.8 Objections to My View4.9 Conclusion; Chapter 5: Informed Consent; 5.1 Trust and Informed Consent; 5.2 The Elements of Consent; 5.3 Disclosure Standards; 5.4 Documentation; 5.5 Consent by Parties Other than the Subject; 5.6 Research Without Consent; 5.7 Opt-Out Consent; 5.8 General Consent; 5.9 Deception in Research; 5.10 Assent; 5.11 Payment for Research Participation; 5.12 The Right to Withdraw; 5.13 Conclusion; Chapter 6: Privacy and Confidentiality; 6.1 Privacy, Confidentiality, andTrust; 6.2 Sharing and Publishing Data andSamples
6.3 Justifiable Breaches of Privacy and Confidentiality6.4 Harm to Self; 6.5 Harm to Others; 6.6 Suspected Abuse/Neglect; 6.7 Communicable Disease Reporting; 6.8 Informing Family Members About Genetic Diseases; 6.9 Conclusion; Chapter 7: Risks; 7.1 What Is Risk?; 7.2 Types of Risk Related to Research Participation; 7.3 Risk and Trust; 7.4 Assessing Risk; 7.5 Minimizing Risk; 7.6 Minimal Risk; 7.7 Research on Healthy Volunteers; 7.8 Phase I Trials on Patients; 7.9 Randomized Controlled Trials; 7.10 Placebo-Controlled Trials; 7.11 Risks to Researchers andThird Parties
2.7 Concerns About Integrity in Biomedical Research2.8 Jesse Gelsinger's Death; 2.9 Concerns About Research on Human Biosamples; 2.10 Conclusion: Human Research Regulations and Guidelines in Historical Context; Chapter 3: Moral Theory; 3.1 What Is a Moral Theory?; 3.2 Moral Subjectivism and Relativism; 3.3 Classifying Moral Theories; 3.4 Divine Command Theory; 3.5 Virtue Ethics; 3.6 Natural Law Theory; 3.7 Utilitarianism; 3.8 Kantianism; 3.9 Natural Rights Theories; 3.10 Pluralistic Theories; 3.11 Conclusion: Toward a Decision-Making Framework
Chapter 4: Trust as a Foundation for Research with Human Subjects4.1 What Is Trust?; 4.2 Trust in Research Involving Research with Human Subjects; 4.3 Trust as a Foundation for the Ethics of Research with Human Subjects: Some Alternative Views; 4.4 Trust as a Foundation for the Ethics of Research with Human Subjects: My View; 4.5 Promoting Trust in Research with Human Subjects; 4.6 The Relationship Between Moral Principles and Research Regulations and Guidelines; 4.7 The Role of Trust in Resolving Ethical Dilemmas in Research withHuman Subjects
4.8 Objections to My View4.9 Conclusion; Chapter 5: Informed Consent; 5.1 Trust and Informed Consent; 5.2 The Elements of Consent; 5.3 Disclosure Standards; 5.4 Documentation; 5.5 Consent by Parties Other than the Subject; 5.6 Research Without Consent; 5.7 Opt-Out Consent; 5.8 General Consent; 5.9 Deception in Research; 5.10 Assent; 5.11 Payment for Research Participation; 5.12 The Right to Withdraw; 5.13 Conclusion; Chapter 6: Privacy and Confidentiality; 6.1 Privacy, Confidentiality, andTrust; 6.2 Sharing and Publishing Data andSamples
6.3 Justifiable Breaches of Privacy and Confidentiality6.4 Harm to Self; 6.5 Harm to Others; 6.6 Suspected Abuse/Neglect; 6.7 Communicable Disease Reporting; 6.8 Informing Family Members About Genetic Diseases; 6.9 Conclusion; Chapter 7: Risks; 7.1 What Is Risk?; 7.2 Types of Risk Related to Research Participation; 7.3 Risk and Trust; 7.4 Assessing Risk; 7.5 Minimizing Risk; 7.6 Minimal Risk; 7.7 Research on Healthy Volunteers; 7.8 Phase I Trials on Patients; 7.9 Randomized Controlled Trials; 7.10 Placebo-Controlled Trials; 7.11 Risks to Researchers andThird Parties