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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. It includes practical information on ethical principles in clinical research, designing appropriate research stu...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Burlington, MA ; London :
Elsevier Academic,
©2006.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Introduction to the art and science of clinical research
- What you need to know about clinical research ethics
- What you need to know about the regulation of clinical research
- Designing a clinical research study
- Selecting subjects for clinical studies
- Risks and benefits in clinical research
- Recruiting subjects
- Informed consent
- Privacy and confidentiality
- The "ethics" section
- Procedures and methods
- Statistics, data collection and management, and record keeping
- Use of human biological materials
- Special issues raised by evolving areas of clinical research
- Case histories : learning from experience.
- What You Need To Know About Research Ethics Before Deciding on What You Want To Study
- Designing a Clinical Research Study
- Writing Consent and Assent Documents
- Getting the Protocol Approved
- Conducting the Study; Special Populations
- Ethical Considerations in Genetics Research
- Ethical Considerations in Use of Tissue for Laboratory Investigations
- Ethical Considerations in Use of Stored Tissue
- Confidentiality Issues
- Research in Emergency Medicine
- Reporting of Adverse Events
- FDA
- Radiation Safety Issues
- Participation of Subjects in Multi-Site Trials
- Participation of Subjects in Multiple Studies
- Conduct of Pharmaceutical Industry Research
- Case Histories, Learning from Experience
- Appendix.