Ethical Considerations When Preparing a Clinical Research Protocol - 2nd Edition - ISBN: 9780123869357

Ethical Considerations When Preparing a Clinical Research Protocol

2nd Edition

Editors: Evan DeRenzo Joel Moss Eric Singer
Paperback ISBN: 9780123869357
Imprint: Academic Press
Published Date: 1st April 2020
Page Count: 320
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Description

Writing Clinical Research Protocols: Ethical Considerations, 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.

Key Features

  • 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

Readership

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

Table of Contents

What You Need To Know About Research Ethics Before Deciding on What You Want To Study Designing a Clinical Research Study Writing Consent and Assent Documents Getting the Protocol Approved Conducting the Study; Special Populations Ethical Considerations in Genetics Research Ethical Considerations in Use of Tissue for Laboratory Investigations Ethical Considerations in Use of Stored Tissue Confidentiality Issues Research in Emergency Medicine Reporting of Adverse Events FDA Radiation Safety Issues Participation of Subjects in Multi-Site Trials Participation of Subjects in Multiple Studies Conduct of Pharmaceutical Industry Research Case Histories, Learning from Experience Appendix

Details

No. of pages:
320
Language:
English
Copyright:
© Academic Press 2020
Published:
Imprint:
Academic Press
Paperback ISBN:
9780123869357

About the Editor

Evan DeRenzo

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

Affiliations and Expertise

Center for Ethics, Washington Hospital Center, Washington, DC, USA

Joel Moss

National Institutes of Health, Bethesda, MD, USA

Affiliations and Expertise

Joel Moss works at the National Institutes of Health, Bethesda, MD, USA

Eric Singer

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

Affiliations and Expertise

Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA

Reviews

"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

Ratings and Reviews