Riding the Green Wave:

Financial Conflicts of Interest inIndustry-Sponsored

Research:A Law and Policy Analysis

Patricia M. Tereskerz

2007. 241 pages.

Softcover: ISBN 978-155572-0841

$24.99 plus $6.75 S&H.

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There is no place where the collapse of the wall between academia and industry is more notable than in the area of biomedical research. Because industry plays such a prominent role in funding research,

and has the potential to greatly impact research integrity, the financial conflicts of interest that are associated with industry are the focus of this book. Riding the Green Wave will assist clinical investigators, members of institutional review boards, health administrators, and attorneys practicing in this area.

"Patti Tereskerz has produced what may be the most comprehensive analysis of the problem of conflict of interest in our healthcare system. Her account should be required reading for policy makers and is a light on dark corners for all of us who will be affected by this complex problem."

Jonathan D. Moreno, PhD, David and Lyn Silfen University Professor , University of Pennsylvania Center for Bioethics


"This book is required reading for everyone interested in developing a better understanding of the nature, extent, and consequences of conflicts of interests in the American life sciences enterprise."
Eric G. Campbell, PhD, Institute for Health Policy , Massachusetts General Hospital, Harvard Medical School


"This book provides an exceptional and thoughtful analysis of the financial intricacies that are the platform of the clinical research in academic research environments today. It is a valuable read for students, administrators, and policy makers interested in understanding financial conflicts of interest in biomedical research."
Mary D. Scheetz, PhD , Former Director of Extramural Research Office of Research Integrity
U.S. Department of Health and Human Services

About the Author

Patricia M. Tereskerz, JD, PhD, is an Associate Professor, Research, and is Director of the Program in Ethics and Policy in Healthcare in the Center for Biomedical Ethics and Humanities at the University of Virginia School of Medicine in Charlottesville. Professor Tereskerz chairs the University of Virginia Conflicts of Interest Committee.

Table of Contents

Acknowledgments

Abbreviations

Introduction

1    An Overview of Clinical Research Funding and Conflicts of Interest: Defining a Financial Conflict of Interest
2    How Financial Conflicts of Interest in Clinical Research Evolved: A Recent Passage through Time
3    The Fallout: Realizing the Effects of Financial Conflicts of Interest in Clinical Research
4    Policies and Regulations on Conflicts of Interest in Research
5    Beyond Federal Regulations: Legal Ramifications of Financial Conflicts of Interest in Clinical Research
6    A Recent Clinical Trial Involving Financial Conflicts of Interest: Applying Traditional Legal Theories
7    Is There a Constitutional Right to be Treated with Dignity within the Context of Medical Experimentation?
8    Financial Conflicts of Interest and Potential Statutory or Regulatory Violations
9    The Other Side of the Coin: Potential Liability for Overly Restrictive Employment Policies
10    Developing a New Model: Preserving Scientific Objectivity, Trust, and the Informed Choices of Human Subjects

Appendices

A    The Nuremberg Code
B    World Medical Association Declaration of Helsinki
C    The Belmont Report
D    45 Code of Federal Regulations Part 46 Including Subpart A, the “Common Rule,” and Supporting Subparts B, C, and D