Tereskerz Clinical Research and the Law

1. Auflage 2012
ISBN: 978-1-118-27216-9
Verlag: John Wiley & Sons
Format: EPUB
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 280 Seiten, E-Book

The legal implications of conducting clinical research andtrials are becoming more complex. Everyone involved in clinicalresearch increasingly needs to be aware of not only the ethicalissues at stake but also how the law affects medical practice andresearch. Much of clinical research and trial law and litigation iscomparatively recent and researchers need to ensure currentcompliance on a wide range of issues. Including:
* standards and duty of care
* informed consent
* conflicts of interest
* research contracts
* establishing clinical trials
* the disclosure and withholding of clinical trial results
Clinical Research and the Law comprehensively discussesthese topics and provides the answers to the legal questions andpotential pitfalls encountered in medical research. It is anup-to-date, practical guide for clinical investigators and theirinstitutional administrators, particularly risk managers andresearch administrators, as well as healthcare administratorsand members of institutional review boards.
This book is also a key resource for medical students,postgraduate research students, practicing attorneys and counselorsfor teaching hospitals and institutions undertaking clinicalresearch and contract research organizations.

Autoren/Hrsg.

Tereskerz, Patricia M.

Inhaltsverzeichnis

Preface
Chapter One: Research Malpractice & Negligence
Chapter Two: Duty of Care: Understanding the Legal
Differences Between Medical Treatment and Medical Research
Chapter Three: Establishing Standard of Care & Violation ofStandard of Care
Chapter Four: Informed Consent in Clinical Research
Chapter Five: Liability Issues for Institutional Review
Boards (IRB's) and Data Safety Monitoring Boards(DSMB's)
Chapter Six: Legal Aspects of Financial Conflicts ofInterest in Clinical Trials
Chapter Seven: Disclosure of Clinical Trial Information: LegalRamifications of Withholding Study Results
Chapter Eight: Clinical Trials & Insider Trading
Chapter Nine: Clinical Trials and Criminal Law
Chapter Ten: Clinical Trial Contracts
Appendix A Glossary
Appendix B NIH Policy on Inclusion of Children as Participantsin Research Involving Human Subjects
Appendix C Best Pharmaceuticals for Children Act p>Appendix DPediatric Research Equity Act 2003
Appendix E Code of Federal Regulations Title 21
Appendix F NCI model contract
Appendix G Conflicts of Interest
Index

Über Autor(innen)

Patricia M. Tereskerz, JD, Ph.D. Associate Professor,Research Director, Program in Ethics & Policy
Patti Tereskerz joined the University of Virginia Center forBiomedical Ethics in the fall of 2001. She is Director of theProgram in Ethics and Policy at the Center and chairs the Conflictsof Interest Committee for the University. Previously she served asAssistant Professor of Internal Medicine and Director of Health Lawand Policy at the University's International Healthcare WorkerSafety Center, where she was a recipient of the AORNJournal's Excellence in Research Award. Prior to joining thefaculty of the Medical School, Tereskerz practiced law with Buck,Hogshire & Tereskerz, Ltd., in Charlottesville, and remains ofcounsel with the firm, now Buck, Toscano &Tereskerz, Ltd.Tereskerz has many publications in areas of both law and medicalresearch, some of which have appeared in the New England Journalof Medicine, the Journal of the American Medical Association(JAMA), and the Milbank Quarterly (See attached CV). Sheand a colleague have recently published several articles on patentlaw and proposed patent reform, including two which appeared inNature Biotechnology and another article is forthcoming in NatureBiotechnology in September. She is also author of a publishedhandbook on needlestick injuries and the law, and is co-author of abook on the prevention and management of occupational exposure toHIV. She has served on various editorial boards.