Writing Clinical Research Protocols
Ethical Considerations
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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.
Key Features
- 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
Readership
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.
Table of Contents
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
- 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
- Procedures and Methods
- Statistics, Data Collection and Management, and Record Keeping
- Use of Human Biological Materials
- Special Issues Raised by Evolving Areas of Clinical Research
- Case Histories: Learning From Experience
Section II. Preparing the Protocol
Section III. Procedures, Methods, Statistics, Data Management, and Record Keeping
Section IV. Special Issues
Appendix: Web Resources
References
Glossary
Index
Product details
- No. of pages: 320
- Language: English
- Copyright: © Academic Press 2005
- Published: August 4, 2005
- Imprint: Academic Press
- Paperback ISBN: 9780122107511
- eBook ISBN: 9780080454207
About the Authors
Evan DeRenzo
Evan DeRenzo works in the Center for Ethics at Washington Hospital Center, Washington, DC, USA
Affiliations and Expertise
Center for Ethics, Washington Hospital Center, Washington, DC, USA
Joel Moss
National Institutes of Health, Bethesda, MD, USA
Affiliations and Expertise
National Institutes of Health, Bethesda, MD, USA
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