Writing Clinical Research Protocols
Ethical Considerations
Published on 8. September 2005
Book
Paperback/Softback
320 pages
978-0-12-210751-1 (ISBN)
Description
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. Writing Clinical Research Protocols 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 is 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.
Reviews / Votes
"This book will be a very useful text and reference source for students and trainees at all levels, as well as for seasoned investigators and RERB members. The continuing proliferation of formal, degree-granting masters and doctoral training programs in clinical investigation at academic centers across the country underscores the need for a book like this. These programs, and the growing acceptance and recognition of professional certification programs for clinical research professionals, are indicators that the expectations we place on investigators are greater than they were just a few years ago. Recognition that good science and good ethics are inextricably bound together in clinical research is today's reality, and this book gives real insight into why and how." --JAMA (February 2006)More details
Language
English
Place of publication
San Diego
United States
Publishing group
Elsevier Science Publishing Co Inc
Target group
Professional and scholarly
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.
Dimensions
Height: 229 mm
Width: 152 mm
Weight
520 gr
ISBN-13
978-0-12-210751-1 (9780122107511)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
New editions
Evan DeRenzo | Eric A. Singer | Joel Moss
Ethical Considerations When Preparing a Clinical Research Protocol
Ethical Considerations
Book
06/2020
2nd Edition
Academic Press
€44.00
Shipment within 15-20 days
Additional editions
E-Book
09/2005
Academic Press
€55.95
Available for download
Persons
Evan DeRenzo works in the Center for Ethics at Washington Hospital Center, Washington, DC, USA National Institutes of Health, Bethesda, MD, USA
Content
Section I. The Basics: What You Need to Know Before Starting Human Subjects Research
Introduction to the Art and Science of Clinical Research
What You Need to Know About Clinical Research Ethics
What You Need to Know About the Regulation of Clinical Research
Section II. Preparing the Protocol
Designing a Clinical Research Study
Selecting Subjects for Clinical Studies
Risks and Benefits in Clinical Research
Recruiting Subjects
Informed Consent
Privacy and Control
The "Ethics" Section
Section III. Procedures, Methods, Statistics, Data Management, and Record Keeping
Procedures and Methods
Statistics, Data Collection and Management, and Record Keeping
Section IV. Special Issues
Use of Human Biological Materials
Special Issues Raised by Evolving Areas of Clinical Research
Case Histories: Learning From Experience
Appendix: Web Resources
References
Glossary
Index
Introduction to the Art and Science of Clinical Research
What You Need to Know About Clinical Research Ethics
What You Need to Know About the Regulation of Clinical Research
Section II. Preparing the Protocol
Designing a Clinical Research Study
Selecting Subjects for Clinical Studies
Risks and Benefits in Clinical Research
Recruiting Subjects
Informed Consent
Privacy and Control
The "Ethics" Section
Section III. Procedures, Methods, Statistics, Data Management, and Record Keeping
Procedures and Methods
Statistics, Data Collection and Management, and Record Keeping
Section IV. Special Issues
Use of Human Biological Materials
Special Issues Raised by Evolving Areas of Clinical Research
Case Histories: Learning From Experience
Appendix: Web Resources
References
Glossary
Index