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Clinical Research and the Law

ISBN-10: 1405195673

ISBN-13: 9781405195676

Edition: 2012

Authors: Patricia M. Tereskerz

List price: $54.50
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Book details

List price: $54.50
Copyright year: 2012
Publisher: John Wiley & Sons, Limited
Publication date: 4/19/2012
Binding: Paperback
Pages: 280
Size: 5.50" wide x 8.50" long x 0.25" tall
Weight: 0.638
Language: English

TerT#60;br#62;#60;p#62;#60;b#62;Patricia M. Tereskerz#60;/b#62;#60;b#62;, JD, Ph.D. #60;/b#62;#60;b#62;Associate Professor, Research#60;/b#62;#60;b#62; Director, Program in Ethics & Policy#60;/b#62;#60;br#62;#60;p#62;Patti Tereskerz joined the University of Virginia Center for Biomedical Ethics in the fall of 2001. She is Director of the Program in Ethics and Policy at the Center and chairs the Conflicts of Interest Committee for the University. Previously she served as Assistant Professor of Internal Medicine and Director of Health Law and Policy at the University's International Healthcare Worker Safety Center, where she was a recipient of the #60;i#62;AORN Journal#8242;#60;/i#62;s Excellence in Research Award. Prior to joining the faculty of the Medical School, Tereskerz practiced law with Buck, Hogshire & Tereskerz, Ltd., in Charlottesville, and remains of counsel with the firm, now Buck, Toscano &Tereskerz, Ltd. Tereskerz has many publications in areas of both law and medical research, some of which have appeared in the #60;i#62;New England Journal of Medicine#60;/i#62;, the #60;i#62;Journal of the American Medical Association (JAMA)#60;/i#62;, and the #60;i#62;Milbank Quarterly#60;/i#62; (See attached CV). She and a colleague have recently published several articles on patent law and proposed patent reform, including two which appeared in Nature Biotechnology and another article is forthcoming in Nature Biotechnology in September. She is also author of a published handbook on needlestick injuries and the law, and is co-author of a book on the prevention and management of occupational exposure to HIV. She has served on various editorial boards.

Preface
Research malpractice and negligence
Background
Drugs: brief description of definitions
Brief overview: conduct of clinical trials
Medical devices
Research malpractice: the basics
Negligence actions and research: interesting aspects of medical research negligence cases
Duty of care: understanding the legal differences between medical treatment and medical research
Establishing duty of care
Do sponsors have a legal duty?
Establishing standard of care and violation of standard of care
Research malpractice and using expert testimony to establish the standard of care
Lessons learned from surgical innovation cases
Standard of care and informed consent cases
Informed consent in clinical research
Basics on informed consent in the clinical treatment setting: background
Informed consent as applied to the research setting
Informed consent and federal regulations
Case law and federal regulations
Clinical trials and pediatric patients
Liability issues for institutional review boards (IRBs) and data safety monitoring boards (DSMBs)
Liability for negligence
Standard of care
Proximate cause and damages
Defense
Practical considerations: the need for indemnification
Special considerations for DSMBs
Legal aspects of financial conflicts of interest in clinical trials
Overview
Legislative background: road to creating financial conflicts of interest
Financial conflicts of interest: evidence that financial conflicts of interest are problematic
Regulations/legislation
Litigation involving financial conflicts of interest in clinical trials
Applying novel legal theories to financial conflicts of interest cases
Other clinical trial cases involving financial conflicts of interest claiming constitutional violations
Disclosure of clinical trial information: legal ramifications of withholding study results
GlaxoSmithKline
Vioxx and Merck
Government and other clinical trial disclosure requirements
Medical journal editors and disclosure of clinical trial information
Clinical trials and insider trading
Purpose of insider trading laws
Proving insider trading
Penalties
Insider trading cases and clinical trials
Beware: investigators and relationships with the investment industry-a risk of recent vintage
Setting the stage
Clinical trials and criminal law
How clinical trial investigators have been implicated in criminal acts
False Claims Act cases and health-care fraud
Clinical trial False Claims Act cases
Enforcement of the False Claims Act against institutions
Anti-kickback law
Health-care fraud
Mail and wire fraud/making false statements to government officials
Proposed new FDA rule
Clinical trial contracts
Key terms/scope of study
Costs/payments
Data
Intellectual property
Indemnification/injuries
Publications
Various sundry provisions
Glossary of common terms used in connection with clinical trials
Research involving human subjects
Best pharmaceuticals for Children Act
Pediatric research Equity Act of 2003
Title 21-food and drugs: additional safeguards for children in clinical investigations
Proposed standardized/harmonized clauses for clinical trial agreements
Responsibility of applicants for promoting objectivity in research for which public health service funding is sought and responsible prospective contractors
Index