Riding the Green Wave: Financial Conflicts of Interest in Industry-Sponsored Research: A Law and Policy Analysis
Patricia M. Tereskerz
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
$24.99, Softcover, 2007, 241 pages.
ISBN 978-155572-0841
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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.
Riding the Green Wave: Financial Conflicts of Interest in Industry-Sponsored Research:
A Law and Policy Analysis
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