Ethical Considerations When Preparing a Clinical Research Protocol

Author:   Evan DeRenzo (Center for Ethics, Washington Hospital Center, Washington, DC, USA) ,  Eric A. Singer (Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA) ,  Joel Moss (National Institutes of Health, Bethesda, MD, USA) ,  Eric A. Singer (Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA)
Publisher:   Elsevier Science Publishing Co Inc
Edition:   2nd edition
ISBN:  

9780123869357


Pages:   370
Publication Date:   11 June 2020
Format:   Paperback
Availability:   Manufactured on demand   Availability explained
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Ethical Considerations When Preparing a Clinical Research Protocol


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Author:   Evan DeRenzo (Center for Ethics, Washington Hospital Center, Washington, DC, USA) ,  Eric A. Singer (Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA) ,  Joel Moss (National Institutes of Health, Bethesda, MD, USA) ,  Eric A. Singer (Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA)
Publisher:   Elsevier Science Publishing Co Inc
Imprint:   Academic Press Inc
Edition:   2nd edition
Weight:   0.600kg
ISBN:  

9780123869357


ISBN 10:   0123869358
Pages:   370
Publication Date:   11 June 2020
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   Manufactured on demand   Availability explained
We will order this item for you from a manufactured on demand supplier.

Table of Contents

1. What You Need To Know About Research Ethics Before Deciding on What You Want To Study 2. Designing a Clinical Research Study 3. Writing Consent and Assent Documents 4. Getting the Protocol Approved 5. Conducting the Study; Special Populations 6. Ethical Considerations in Genetics Research 7. Ethical Considerations in Use of Tissue for Laboratory Investigations 8. Ethical Considerations in Use of Stored Tissue 9. Confidentiality Issues 10. Research in Emergency Medicine 11. Reporting of Adverse Events 12. FDA 13. Radiation Safety Issues 14. Participation of Subjects in Multi-Site Trials 15. Participation of Subjects in Multiple Studies 16. Conduct of Pharmaceutical Industry Research 17. Case Histories, Learning from Experience

Reviews

Review of the previous edition: This book will be a very useful text and reference source for students and trainees at all levels, as well as for seasoned investigators and RERB members. The continuing proliferation of formal, degree-granting masters and doctoral training programs in clinical investigation at academic centers across the country underscores the need for a book like this. These programs, and the growing acceptance and recognition of professional certification programs for clinical research professionals, are indicators that the expectations we place on investigators are greater than they were just a few years ago. Recognition that good science and good ethics are inextricably bound together in clinical research is today's reality, and this book gives real insight into why and how. --JAMA, February 2006


This book will be a very useful text and reference source for students and trainees at all levels... - JAMA (February 2006)


Author Information

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

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