Ethical Considerations When Preparing a Clinical Research Protocol

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 protocolIncludes case histories that illustrate key points Contains information on conducting clinical research within the pharmaceutical industryIncludes internet resources and worldwide web addresses for important research ethics documents and regulationsContains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations

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 Tissue
9. 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 Trials
15. Participation of Subjects in Multiple Studies
16. Conduct of Pharmaceutical Industry Research
17. Case Histories, Learning from Experience