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.

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Bibliographic Details

Title: Ethical Considerations When Preparing a Clinical Research Protocol
Publisher: Elsevier Science Publishing Co Inc, US
Publication Date: 2020
Language: English
ISBN 10: 0123869358
ISBN 13: 9780123869357
Binding: Paperback
Edition: 2nd Edition
Condition: New
Weight: 600 grams

About this title

Synopsis

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

About the Authors

Evan DeRenzo works in the Center for Ethics at Washington Hospital Center, Washington, DC, USA

Eric Singer works at the Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA

National Institutes of Health, Bethesda, MD, USA

"About this title" may belong to another edition of this title.

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