Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary

Book 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.

• Format: Paperback
• Language: English
• ISBN: 0801878136
• ISBN13: 9780801878138
• Release Date: January 2004
• Publisher: Johns Hopkins University Press
• Length: 528 Pages
• Weight: 3.23 lbs.
• Dimensions: 1.2" x 8.4" x 10.9"
• Grade Range: Postsecondary and higher

Customer Reviews

Excellent Reference

This book is a great resource and reference. It's a great collection of short articles useful for those interested in the ethical issues surrounding research. It has full copies of the Nuremberg and other ethical codes.

Very informative

This book is an excellent textbook for bioethics with wonderful framework, comprehensive approach, and many relevant articles. You can get overall outline and detailed information & discussion on bioethics by this book, therefore this book is good for beginner as well as for expert on this field.