Ethical Considerations When Preparing a Clinical Research Protocol

by Evan DeRenzo, Eric A. Singer, Joel Moss

Overview

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

Product Details

ISBN-13:	9780123869548
Publisher:	Elsevier Science & Technology Books
Publication date:	06/12/2020
Sold by:	Barnes & Noble
Format:	eBook
Pages:	370
File size:	2 MB

About the Author

Evan DeRenzo works in the Center for Ethics at Washington Hospital Center, Washington, DC, USAEric Singer works at the Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USANational Institutes of Health, Bethesda, MD, USA

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 Tissue9. 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 Trials15. Participation of Subjects in Multiple Studies16. Conduct of Pharmaceutical Industry Research 17. Case Histories, Learning from Experience

What People are Saying About This

From the Publisher

A practical guide for clinical researchers on the ethical requirements for the design and conduct of clinical research

Editorial Reviews

Reviewer: CARSON ROBERT REIDER, BA MS PhD(The Ohio State University)
Description: The second edition of this book covers a broad spectrum of salient topics related to the development and implementation of clinical research protocols with particular emphasis on intervention studies, i.e., clinical trials. The first edition was published under the title, Writing Clinical Research Protocols- Ethical Considerations, DeRenzo (Elsevier, 2006), with the second edition following in 2020.
Purpose: This book is to serve as a broad foundational text for clinical researchers and has that potential across the majority of salient domains relevant to conducting ethical clinical research.
Audience: This book will benefit novice and intermediate clinical researchers. This population includes graduate students, post-docs, residents, fellows, junior faculty, clinical research assistants, coordinators, and managers. Readers should complement, but not limit, their reading with more in-depth texts concerning study design, recruitment, and data and safety monitoring.
Features: The book is organized into four sections that cover basic ethical and regulatory guidelines; operations to be considered when writing the protocol; methods including study design, analysis, and data management; and a final section on special ethical concerns for sample collection and interventions with some specific case presentations as examples.
Assessment: It has been over 10 years since the initial edition of this text. This second edition serves as a more updated, comprehensive, cursory reference toward the ethical considerations necessary for developing and implementing clinical research studies. The publication's most important message is delivered in section A.2.3., yet, it is a thread throughout the book: knowing the basic ethical principles as well as regulations relevant to clinical research are not enough; rather, it takes mentoring, discussing, and resolving constructs and concerns through a team approach, which may be raised and delivered by a clinical research protocol. My criticism of the book is that there is an unsettling lack of attention to the clinical research ethical requirement of "respect for enrolled subjects" as originally published by Emanuel et al. in 2000. The application of this principle is to be realized in the study monitoring processes that maximize benefit and minimize risk; those processes being commensurate with the level of risk offered by the study design, intervention, and/or population and environment in which the protocol will be conducted, as well as the personnel by which it will be conducted. Of particular note is that this monitoring may (or may not) call for independent monitoring outside of the study team as well as Institutional Review Board (IRB). The material of the text appears to be limited to the concept of a Data and Safety Monitoring Board, which is only briefly mentioned and, as only a recent phenomenon, not so! While there are other publications that more fully address the ethical principle of "respect for enrolled subjects," it would be beneficial for this book to expound on this ethical principle and how it can be achieved during study conduct, as the book presents other ethical principles that are primarily applied during protocol development and initiation.

Doody's Review Service

"It has been over 10 years since the initial edition of this text. This second edition serves as a more updated, comprehensive, cursory reference toward the ethical considerations necessary for developing and implementing clinical research studies. The publication's most important message is delivered in section A.2.3., yet, it is a thread throughout the book: knowing the basic ethical principles as well as regulations relevant to clinical research are not enough; rather, it takes mentoring, discussing, and resolving constructs and concerns through a team approach, which may be raised and delivered by a clinical research protocol. My criticism of the book is that there is an unsettling lack of attention to the clinical research ethical requirement of "respect for enrolled subjects" as originally published by Emanuel et al. in 2000. The application of this principle is to be realized in the study monitoring processes that maximize benefit and minimize risk; those processes being commensurate with the level of risk offered by the study design, intervention, and/or population and environment in which the protocol will be conducted, as well as the personnel by which it will be conducted. Of particular note is that this monitoring may (or may not) call for independent monitoring outside of the study team as well as Institutional Review Board (IRB). The material of the text appears to be limited to the concept of a Data and Safety Monitoring Board, which is only briefly mentioned and, as only a recent phenomenon, not so! While there are other publications that more fully address the ethical principle of "respect for enrolled subjects," it would be beneficial for this book to expound on this ethical principle and how it can be achieved during study conduct, as the book presents other ethical principle that are primarily applied during protocol development and initiation." —Doody

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

From the Publisher