Ethical Considerations When Preparing a Clinical Research Protocol
2nd Edition
Description
Writing Clinical Research Protocols: Ethical Considerations, Second Edition 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, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more.
Key Features
- Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol
- Includes case histories that illustrate key points
- Contains information on conducting clinical research within the pharmaceutical industry
- Includes internet resources and worldwide web addresses for important research ethics documents and regulations
- Contains a chapter on Study Design and Methodology that is 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
- What You Need To Know About Research Ethics Before Deciding on What You Want To Study
2. Designing a Clinical Research Study
3. Writing Consent and Assent Documents
4. Getting the Protocol Approved
5. Conducting the Study; Special Populations
6. Ethical Considerations in Genetics Research
7. Ethical Considerations in Use of Tissue for Laboratory Investigations
8. Ethical Considerations in Use of Stored Tissue
9. Confidentiality Issues
10. Research in Emergency Medicine
11. Reporting of Adverse Events
12. FDA
13. Radiation Safety Issues
14. Participation of Subjects in Multi-Site Trials
15. Participation of Subjects in Multiple Studies
16. Conduct of Pharmaceutical Industry Research
17. Case Histories, Learning from Experience
Details
- No. of pages:
- 320
- Language:
- English
- Copyright:
- © Academic Press 2020
- Published:
- 1st April 2020
- Imprint:
- Academic Press
- Paperback ISBN:
- 9780123869357
About the Editor
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
Joel Moss works at the National Institutes of Health, Bethesda, MD, USA
Eric Singer
Eric Singer works at the Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA
Affiliations and Expertise
Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA
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