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