Table of Contents

Contributors

Preface

Acknowledgments

Chapter 1. A Historical Perspective on Clinical Research

The Earliest Clinical Research

Greek and Roman Influence

Middle Ages and Renaissance

Seventeenth Century

Eighteenth Century

Nineteenth Century

Twentieth Century and Beyond

Acknowledgment

Summary Questions

REFERENCES

Part I Ethical, Regulatory and Legal Issues

Chapter 2. Ethical Principles in Clinical Research

Distinguishing Clinical Research from Clinical Practice

What does Ethics have to do with Clinical Research?

History of Ethical Attention to Clinical Research

Codes of Research Ethics and Regulations

Ethical Framework for Clinical Research

Ethical Considerations in Randomized Clinical Trials

Conclusion

Summary Questions

REFERENCES

Chapter 3. Researching a Bioethical Question

Types of Bioethical Issues

Types of Bioethical Research Methodologies

Examples of Important Bioethical Research

Special Considerations in Bioethical Research

REFERENCES AND NOTES

Chapter 4. Integrity in Research

Guidelines for the Conduct of Research

Scientific Integrity and Misconduct

Mentor–Trainee Relationships

Data Acquisition, Management, Sharing, and Ownership

Research Involving Human and Animal Subjects

Collaborative Science

Conflict of Interest and Commitment

Peer Review

Publication Practices and Responsible Authorship

Acknowledgment

Summary Questions

REFERENCES

Chapter 5. Institutional Review Boards

Historical, Ethical, and Regulatory Foundations of Current Requirements for Research Involving Human Subjects

Institutional Review Boards

Clinical Researchers and IRBS

The Current IRB System Under Evaluation

Details

No. of pages:
796
Language:
English
Copyright:
© 2012
Published:
Imprint:
Academic Press
Print ISBN:
9780123821676
Electronic ISBN:
9780123821683

Reviews

PRAISE FOR THE FIRST EDITION:
"...much needed and provides essentially all of the basic information required by investigators involved in clinical research. ...an important resource for institutional libraries..."—THE NEW ENGLAND JOURNAL OF MEDICINE
"...it really is a step-by-step DIY book for the uninitiated proposal writer. Full of practical advice, top tips and the ever-useful 'Supplemental reading' section, it even has a sample face sheet and a study design 'tick list'."--IMMUNOLOGY NEWS

"Principles and Practice of Clinical Research, 3rd Edition is 80% larger than the second edition.  Most of the authors are with the National Institutes of Health, but the material is largely applicable to both government- and industry-funded research…This book has been selected for The First Clinical Research Bookshelf, essential reading for clinical research professionals."--Journal of Clinical Research Best Practices, May 2013