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Writing Clinical Research Protocols: Ethical Considerations de Evan DeRenzo

Writing Clinical Research Protocols: Ethical Considerations

Autor Evan DeRenzo, Joel Moss
en Limba Engleză Paperback – 7 sep 2005
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.

  • 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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Specificații

ISBN-13: 9780122107511
ISBN-10: 0122107519
Pagini: 320
Dimensiuni: 152 x 229 x 18 mm
Greutate: 0.43 kg
Editura: ELSEVIER SCIENCE

Public țintă

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.

Cuprins

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 Section II. Preparing the Protocol
  4. Designing a Clinical Research Study
  5. Selecting Subjects for Clinical Studies
  6. Risks and Benefits in Clinical Research
  7. Recruiting Subjects
  8. Informed Consent
  9. Privacy and Control
  10. The "Ethics" Section Section III. Procedures, Methods, Statistics, Data Management, and Record Keeping
  11. Procedures and Methods
  12. Statistics, Data Collection and Management, and Record Keeping Section IV. Special Issues
  13. Use of Human Biological Materials
  14. Special Issues Raised by Evolving Areas of Clinical Research
  15. Case Histories: Learning From Experience
Appendix: Web Resources
References
Glossary
Index

Recenzii

"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)