Ethical Considerations When Preparing a Clinical Research Protocol, 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.

• 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

Evan DeRenzo works in the Center for Ethics at Washington Hospital Center, Washington, DC, USAEric Singer works at the Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USANational Institutes of Health, Bethesda, MD, USA

1. 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 Tissue9. 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 Trials15. Participation of Subjects in Multiple Studies16. Conduct of Pharmaceutical Industry Research 17. Case Histories, Learning from Experience