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.
1. Chapter One: Introduction to the ethics and science of clinical research - p. page_xiii 2. Chapter Two: What you need to know about clinical research ethics - p. page_11 3. Chapter Three: What you need to know about the regulation of clinical research - p. page_29 4. Section B: Preparing the protocol - p. page_50 5. Chapter Four: Designing a clinical research study - p. page_50 6. Chapter Five: Selecting the research population for a clinical study - p. page_75 7. Chapter Six: Risks and benefits in clinical research - p. page_113 8. Chapter Seven: Recruiting research participants - p. page_139 9. Chapter Eight: Informed consent - p. page_148 10. Chapter Nine: Privacy and confidentiality - p. page_188 11. Chapter Ten: The “Ethics” section - p. page_206 12. Section C: Procedures, methods, statistics, data management, and record keeping - p. page_213 13. Chapter Eleven: Methods and procedures - p. page_213 14. Chapter Twelve: Statistics, data collection and management, and record keeping - p. page_238 15. Section D: Special ethical issues - p. page_253 16. Chapter Thirteen: Use of human biological materials - p. page_253 17. Chapter Fourteen: Special issues raised by evolving areas of clinical research - p. page_270 18. Chapter Fifteen: Cautionary tales: Learning from experience - p. page_298 19. Glossary - p. page_311 20. References - p. page_319 21. Index - p. page_345
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.
1. Chapter One: Introduction to the ethics and science of clinical research - p. page_xiii 2. Chapter Two: What you need to know about clinical research ethics - p. page_11 3. Chapter Three: What you need to know about the regulation of clinical research - p. page_29 4. Section B: Preparing the protocol - p. page_50 5. Chapter Four: Designing a clinical research study - p. page_50 6. Chapter Five: Selecting the research population for a clinical study - p. page_75 7. Chapter Six: Risks and benefits in clinical research - p. page_113 8. Chapter Seven: Recruiting research participants - p. page_139 9. Chapter Eight: Informed consent - p. page_148 10. Chapter Nine: Privacy and confidentiality - p. page_188 11. Chapter Ten: The “Ethics” section - p. page_206 12. Section C: Procedures, methods, statistics, data management, and record keeping - p. page_213 13. Chapter Eleven: Methods and procedures - p. page_213 14. Chapter Twelve: Statistics, data collection and management, and record keeping - p. page_238 15. Section D: Special ethical issues - p. page_253 16. Chapter Thirteen: Use of human biological materials - p. page_253 17. Chapter Fourteen: Special issues raised by evolving areas of clinical research - p. page_270 18. Chapter Fifteen: Cautionary tales: Learning from experience - p. page_298 19. Glossary - p. page_311 20. References - p. page_319 21. Index - p. page_345
