Ethical Considerations When Preparing a Clinical Research Protocol

Evan DeRenzo works in the Center for Ethics at Washington Hospital Center, Washington, DC, USA Eric Singer works at the Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA National 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