Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary / Edition 1

by Ezekiel J. Emanuel MD PhD, Robert A. Crouch PhD, John D. Arras PhD, Jonathan D. Moreno PhD

Overview

All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested.

Product Details

ISBN-13:	9780801878138
Publisher:	Johns Hopkins University Press
Publication date:	01/01/2004
Edition description:	New Edition
Pages:	528
Product dimensions:	8.50(w) x 11.00(h) x 1.25(d)
Age Range:	18 Years

About the Author

Ezekiel J. Emanuel, M.D., Ph.D., is Chair of the Department of Clinical Bioethics at the Warren G. Magnuson Clinical Center at the National Institutes of Health. Robert A. Crouch, M.A., is an Assistant Professor in the Biomedical Ethics Unit and the Department of Social Studies of Medicine at McGill University. John D. Arras, Ph.D., is Porterfield Professor of Biomedical Ethics and Professor of Philosophy at the University of Virginia. Jonathan D. Moreno, Ph.D., is Director of the Center for Biomedical Ethics at the University of Virginia. Christine Grady, R.N., Ph.D., is Head, Section on Human Subjects Research in the Department of Clinical Bioethics at the National Institutes of Health.

Table of Contents

Part I. Scandals and Tragedies of Research with Human Participants: Nuremberg, the Jewish Chronic Disease Hospital, Beecher, and Tuskegee
Part II. Ethical and Regulatory Guidance for Research with Humans
Part III. The Ethics of Clinical Trial Design
Part IV. The Ethics of Research Participant RecruitmentPart V. Informed Consent in Research
Part VI. Clinical Research with Special Populations
Part VII. Special Topics in Research Ethics
Part VIII. The Behavior of Clinical Investigators: Conflicts of Interest
Part IX. Scientific Misconduct
Part X. Challenges to the Institutional Review Board System

Editorial Reviews

Provides excellent material on a broad variety of ethical topics in clinical research. The editors are commended for the wise and diverse selection of articles and the broad range of sources of literature included. A lot of information is made available at a very affordable price.
--Quality Assurance Journal

Many of the chapters easily deserve to be required reading . . . Most of the readings that have been chosen for the book can lay claim to being classics. They represent sophisticated thinking on various topics.
--Leonardo D. de Castro, Bulletin of the World Health Organization

One word will suffice to describe the book--outstanding.
--Sanjay A. Pai, Current Science

From the Publisher

Provides excellent material on a broad variety of ethical topics in clinical research. The editors are commended for the wise and diverse selection of articles and the broad range of sources of literature included. A lot of information is made available at a very affordable price.

Quality Assurance Journal

One word will suffice to describe the book—outstanding.

Current Science - Sanjay A. Pai

Many of the chapters easily deserve to be required reading . . . Most of the readings that have been chosen for the book can lay claim to being classics. They represent sophisticated thinking on various topics.

Bulletin of the World Health Organization - Leonardo D. de Castro

Many of the chapters easily deserve to be required reading... Most of the readings that have been chosen for the book can lay claim to being classics. They represent sophisticated thinking on various topics.

— Leonardo D. de Castro

Bulletin of the World Health Organization

One word will suffice to describe the book—outstanding.

— Sanjay A. Pai

Current Science