Writing Clinical Research Protocols: Ethical Considerations

·
· Elsevier
4.5
2 reviews
Ebook
320
Pages
Eligible
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About this ebook

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. - 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

Ratings and reviews

4.5
2 reviews
A Google user
May 31, 2008
A timely balanced and thoughtful book combining important reference material, practical real world issues and broadly informed perspective that allow healthy dialogue among physicians, government, the public and the device and drug industries. An important step toward clearing the air and setting a course for de-risking physician-industry interactions and aligning incentives for improving patient care. Physicians and the public are exposed to polarized, incomplete and biased debates about how physicians and their organizations should manage their relationships with industry. This book gives one the wisdom and confidence to find the best balance between avoidance of conflicts and achieving the highest benefits for patients.
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A Google user
July 19, 2009
This is a very detailed book about ethical issues happened in true biological research cases. As a scientific researcher, I had real experience about some research blind spots described in the book. It is a good book not only for clinical researchers but also other biological researchers, for it reminds us a lot of things we need to think twice before conducting or even designing our experiments.
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About the author

Evan DeRenzo works in the Center for Ethics at Washington Hospital Center, Washington, DC, USANational Institutes of Health, Bethesda, MD, USA

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