The Oxford Textbook of Clinical Research Ethics

by Emanuel, Ezekiel J.; Grady, Christine C.; Crouch, Robert A.; Lie, Reidar K.; Miller, Franklin G.; Wendler, David D.

• ISBN13: 9780195168655
• ISBN10: 0195168658
• Edition: 1st
• Format: Hardcover
• Copyright: 2008-04-18
• Publisher: Oxford University Press

Summary

The Oxford Textbook of Clinical Research Ethics is the first systematic and comprehensive reference on clinical research ethics. Under the editorship of experts from the National Institute of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering historical triumphs of research as well as tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the textbook examines issues ranging from scientific validity, fair subject selection, risk benefit ration, independent review, and informed consent as well as focused consideration of international research ethics, conflicts of interests and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research with human beings. Comprehensive in scope and research, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students alike.

Author Biography

Ezekiel J. Emanuel is Chair of the Department of Bioethics at the National Institutes of Health.

Christine Grady is Head of the Section on Human Subjects Research at the Department of Bioethics at the National Institutes of Health.

Robert A. Crouch is at The Poynter Center for the Study of Ethics and American Institutions at Indiana University.

Reidar K. Lie is Head of International Programs in the Department of Bioethics at the National Institutes of Health.

Franklin G. Miller is on the faculty of the Department of Bioethics at the National Institutes of Health.

David Wendler is Head of the Unit on Vulnerable Populations in the Department of Bioethics at the National Institutes of Health.

Table of Contents

Contributors

Acknowledgements and Permission

Introduction

The History of Research with Humans

Walter Reed and the Yellow Fever Experiments

The Nazi Medical Experiments

The Imperial Japanese Experiments in China

The Randomized Controlled Trial of Streptomycin

The Salk Polio Vaccine Field Trial of 1954

The Jewish Chronic Disease Hospital Case

The Hepatitis Experiments at the Willowbrook State School

The Tuskegee Syphillis Experiment

HIV Research

The Gelsinger Case

An Ethical Framework for Biomedical Research

Codes, Declarations, and Other Ethical Guidance for Research with Humans

The Nuremberg Code

The Declaration of Helsinki

The Belmont Report

Regulations for the Protection

International Ethical Guidance from the Council for International Organizations of Medical Sciences

The Council of Europe

The European Community Directives on Data Protection and Clinical Trials

National Bioethics Commissions and Research

Context, Purpose and Value of Clinical Research

Exploitation in Clincial Research

The Nature, Scope, and Justification of Clinical Research: What is Research? Who is a Subject?

Four Paradigms of Clinical Research and Research Oversight

The Role of Patient Advocates and Public Representatives in Research

Scientific Design

Equipoise and Randomization

The Ethics of Placebo-Controlled Trials

Challenge Experiments

Emergency Research

Consent for Research with Biological Samples

Genetic Diagnostic, Pedigree, and Screening Research

Deception in Clinical Research

Ethics of Epidemiology: Observational Studies of Human Populations

Ethical Issues in Behavioral and Social Science Research

Phase 1 Oncology Research

Surgical Innovation and Research

Participant Selection

What is Fair Participant Selection?

Incentives for Research Participants

Ethical Issues in Recruiting Research Participants

Ethical Issues in Research Involving Women

Ethical Issues in Research with Ethnic and Minority Populations

Research Involving Economically Disadvantaged Participants

Research Involving Those At risk for Impaired Decision-making Capacity

Research with Children

Captive Populations: Prisoners, Students and Soldiers

Research with Identifiable and Targeted Communities

Research with Healthy Volunteers

Research with Fetuses, Embryos, and Stem Cells

Risk-Benefit Assessments

Risk-Benefit Analysis adn the Net Risks Test

Assesseing and Comparing Potential Benefits and Risks of Harm

Risk-Benefit Assessment in Pediatric Research

Independent Review and Oversight

Institutional Review Boards: Their Origins and the Policies that Govern Them

Models of Institutional Review Board Function

Evaluating the Effectiveness of Institutional Review Boards

Data and Safety Monitoring Boards

The Food and Drug Administration and Drug Development: Historic, Scientific, and Ethical Considerations

Informed Consent

A History of Informed Consent in Clinical Research

Philosophical Justifications of Informed Consent in Research

Legal and Regulatory Standards of Informed Consent in Research

The Therapeutic Misconception

Empirical Issues in Informed Consent for Research

The Assent Requirement in Pediatric Research

Respect for Human Research Participants

Confidentiality

Legal Responsibility to Research Subjects: Liability and Compensation for Injury

The Obligation to Ensure Access to Beneficial Treatments for Research Participants at Conclusion of Clinical Trials

Multi-National Research

Appropriate Ethical Standards

Benefits to Host Countries

The Standard of Care in Multi-National Research

Responsiveness to Host Community Health Needs

Clinical Investigator Behavior

Conflicts of Interest in Medical Research: Historical Developments

Conflictso f Interest

Empirical Data on Conflicts of Interest

Industrialization of Aca

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