نوشتن پروتکل‌های تحقیق بالینی: ملاحظات اخلاقی

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 studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This will be an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. * Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol * Includes a chapter containing Case Histories * Contains information on conducting clinical research within the pharmaceutical industry * An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations * Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations Content: Preface , Pages xvii-xix chapter 1 - Introduction to the Art and Science of Clinical Research , Pages 3-10 chapter 2 - What You Need to Know About Clinical Research Ethics , Pages 11-25 chapter 3 - What You Need to Know About the Regulation of Clinical Research , Pages 27-39 chapter 4 - Designing a Clinical Research Study , Pages 43-61 chapter 5 - Selecting Subjects for Clinical Studies , Pages 63-96 Chapter 6 - Risks and Benefits in Clinical Research , Pages 97-118 chapter 7 - Recruiting Subjects , Pages 119-125 chapter 8 - Informed Consent , Pages 127-158 chapter 9 - Privacy and Confidentiality , Pages 159-174 chapter 10 - The “Ethics” Section , Pages 175-181 chapter 11 - Procedures and Methods , Pages 185-205 chapter 12 - Statistics, Data Collection and Management, and Record Keeping , Pages 207-220 chapter 13 - Use of Human Biological Materials , Pages 223-235 chapter 14 - Special Issues Raised by Evolving Areas of Clinical Research , Pages 237-259 chapter 15 - Case Histories: Learning from Experience , Pages 261-268 Appendix - Web Resources , Pages 269-272 References , Pages 273-280 Glossary , Pages 281-289 Index , Pages 291-300 In the last 50 years, there has been an exponential increase in the number of research studies, as well as greater media and public scrutiny of researchers and the research process. Writing Clinical Research Protocols: Ethical Considerations is designed to give researchers and research education programs a single source that investigators and support staff can use. This book includes a wide range of ethical considerations that need to be addressed in the course of designing and gaining approval for a human research study.The current literature on ethics for clinical researchers is limited. That which exists tends to focus on a particular area of research ethics, such as consent or Institutional Review Boards. This book offers the researcher guidelines on writing protocols from the perspective of the ethical judgments to be made within each section of the protocol and consent documents. Writing Clinical Research Protocols: Ethical Considerations thus fills a conspicuous void in the research literature. 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. Writing Clinical Research Protocols includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This is an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. "This book includes a wide range of ethical considerations that need to be addressed in the course of designing and gaining approval for a human research study. The current literature on ethics for clinical researchers is limited. That which exists tends to focus on a particular area of research ethics, such as consent or Institutional Review Boards. This book offers the researcher guidelines on writing protocols from the perspective of the ethical judgments to be made within each section of the protocol and consent documents. Writing Clinical Research Protocols: Ethical Considerations thus fills a conspicuous void in the research literature."--BOOK JACKET A practical guide for clinical researchers that aims to improve their skills in the understanding of the ethical requirements for the design and conduct of clinical research. Includes information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events