Writing Clinical Research Protocols

Ethical Considerations

By

  • Evan DeRenzo, Center for Ethics at Washington Hospital Center, Washington, DC, U.S.A
  • Joel Moss, National Institutes of Health, Bethesda, MD, U.S.A.

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.
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Audience

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.

 

Book information

  • Published: August 2005
  • Imprint: ACADEMIC PRESS
  • ISBN: 978-0-12-210751-1

Reviews

"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)



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

References

Glossary

Index