Writing Clinical Research Protocols: Ethical Considerations (Paperback)

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