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. 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

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Editorial Reviews

From the Publisher
"This book will be a very useful text and reference source for students and trainees at all levels..."
- JAMA (February 2006)
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Product Details

  • ISBN-13: 9780122107511
  • Publisher: Elsevier Science
  • Publication date: 8/18/2005
  • Edition description: New Edition
  • Pages: 320
  • Sales rank: 1,246,781
  • Product dimensions: 0.68 (w) x 6.00 (h) x 9.00 (d)

Table of Contents

Section I. The Basics: What You Need to Know Before Starting Human Subjects Research

  1. Introduction to the Art and Science of Clinical Research
  2. What You Need to Know About Clinical Research Ethics
  3. What You Need to Know About the Regulation of Clinical Research
  4. Section II. Preparing the Protocol

  5. Designing a Clinical Research Study
  6. Selecting Subjects for Clinical Studies
  7. Risks and Benefits in Clinical Research
  8. Recruiting Subjects
  9. Informed Consent
  10. Privacy and Control
  11. The "Ethics" Section
  12. Section III. Procedures, Methods, Statistics, Data Management, and Record Keeping

  13. Procedures and Methods
  14. Statistics, Data Collection and Management, and Record Keeping
  15. Section IV. Special Issues

  16. Use of Human Biological Materials
  17. Special Issues Raised by Evolving Areas of Clinical Research
  18. Case Histories: Learning From Experience

Appendix: Web Resources




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