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Summary:

This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight. This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust.

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

Author/Creator:

Resnik, David B. , author

Languages:

English

Language Notes:

Item content: English

Main Work:

The ethics of research with human subjects: protecting people, advancing science, promoting trust [by Resnik, D.B.]

Related Series:

International library of ethics, law, and the new medicine; v. 74

Subjects:

Human experimentation in medicine — Moral and ethical aspects

Medicine — Research — Moral and ethical aspects

Research — Moral and ethical aspects

Medical ethics

Human experimentation in medicine

Medicine

Research

General Notes:

Includes bibliographical references and index.
Description based on: Print version record.

Physical Description:

1 online resource.

Digital Characteristics:

text file

Call Numbers:

R853.H8 R476 2018eb

ISBNs:

9783319687568 (electronic bk.)
3319687565 (electronic bk.)
3319687557 [Invalid]
9783319687551 [Invalid]
9783319687575 (print)
3319687573
9783319886541 (print)
3319886541

Other Standard Numbers:

Digital Object Identifier: 10.1007/978-3-319-68756-8

OCLC Numbers:

1018944854