Back to Results
Cover image of Ethical and Regulatory Aspects of Clinical Research
Cover image of Ethical and Regulatory Aspects of Clinical Research
Share this Title:

Ethical and Regulatory Aspects of Clinical Research

Readings and Commentary

edited by Ezekiel J. Emanuel, M.D., Ph.D., Robert A. Crouch, M.A., John D. Arras, Ph.D., Jonathan D. Moreno, Ph.D., and Christine Grady, R.N., Ph.D.

Publication Date
Binding Type

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...

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.

Reviews

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.

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.

One word will suffice to describe the book—outstanding.

About

Book Details

Publication Date
Status
Available
Trim Size
8.5
x
11
Pages
528
ISBN
9780801878138
Illustration Description
2 line drawings
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

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

Author Bios
Featured Contributor

Ezekiel J. Emanuel, M.D., Ph.D.

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.
Featured Contributor

John D. Arras, Ph.D.

John D. Arras, Ph.D., is Porterfield Professor of Biomedical Ethics and Professor of Philosophy at the University of Virginia.