Writing Clinical Research Protocols. Ethical Considerations

✍ Scribed by Evan G. DeRenzo, Ph.D., and Joel Moss, M.D., Ph.D. (Auth.)

• Publisher: Academic Press
• Year: 2006
• Tongue: English
• Leaves: 286
• Edition: 1
• Category: Library

✦ Synopsis

This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This will be an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process.

Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol
Includes a chapter containing Case Histories
Contains information on conducting clinical research within the pharmaceutical industry
An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations
* Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations

✦ Table of Contents

Content:
Preface, Pages xvii-xix
chapter 1 - Introduction to the Art and Science of Clinical Research, Pages 3-10
chapter 2 - What You Need to Know About Clinical Research Ethics, Pages 11-25
chapter 3 - What You Need to Know About the Regulation of Clinical Research, Pages 27-39
chapter 4 - Designing a Clinical Research Study, Pages 43-61
chapter 5 - Selecting Subjects for Clinical Studies, Pages 63-96
Chapter 6 - Risks and Benefits in Clinical Research, Pages 97-118
chapter 7 - Recruiting Subjects, Pages 119-125
chapter 8 - Informed Consent, Pages 127-158
chapter 9 - Privacy and Confidentiality, Pages 159-174
chapter 10 - The “Ethics” Section, Pages 175-181
chapter 11 - Procedures and Methods, Pages 185-205
chapter 12 - Statistics, Data Collection and Management, and Record Keeping, Pages 207-220
chapter 13 - Use of Human Biological Materials, Pages 223-235
chapter 14 - Special Issues Raised by Evolving Areas of Clinical Research, Pages 237-259
chapter 15 - Case Histories: Learning from Experience, Pages 261-268
Appendix - Web Resources, Pages 269-272
References, Pages 273-280
Glossary, Pages 281-289
Index, Pages 291-300