Writing Clinical Research Protocols: Ethical Considerations

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 protocolIncludes a chapter containing Case HistoriesContains information on conducting clinical research within the pharmaceutical industryAn appendix includes internet resources and world wide web addresses for important research ethics documents and regulationsChapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations

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