Tereskerz | Clinical Research and the Law | Buch | 978-1-4051-9567-6 | www.sack.de

Buch, Englisch, 180 Seiten, Format (B × H): 140 mm x 216 mm, Gewicht: 359 g

Tereskerz

Clinical Research and the Law


1. Auflage 2012
ISBN: 978-1-4051-9567-6
Verlag: Wiley

Buch, Englisch, 180 Seiten, Format (B × H): 140 mm x 216 mm, Gewicht: 359 g

ISBN: 978-1-4051-9567-6
Verlag: Wiley

This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research. It encompasses legal and ethical issues such as duty of care, research malpractice and negligence, standards of care, informed consent, liability issues for Institutional Review Boards (IRB), conflicts of interest, insider trading and the disclosure and withholding of clinical trial results. It will also provide legal guidance on research contracts, setting up clinical trials and common legal pitfalls encountered in medical research.

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Autoren/Hrsg.

Tereskerz, Patricia M

Fachgebiete

Weitere Infos & Material

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 of Standard 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 of Interest in Clinical Trials

Chapter Seven: Disclosure of Clinical Trial Information: Legal Ramifications 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 Participants in Research Involving Human Subjects

Appendix C Best Pharmaceuticals for Children Act p>Appendix D Pediatric Research Equity Act 2003

Appendix E Code of Federal Regulations Title 21

Appendix F NCI model contract

Appendix G Conflicts of Interest

Index

Tereskerz, Patricia M
Patricia M. Tereskerz, JD, Ph.D. Associate Professor, Research Director, Program in Ethics & Policy
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 AORN Journal'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 New England Journal of Medicine, the Journal of the American Medical Association (JAMA), and the Milbank Quarterly (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.

Patricia M. Tereskerz, JD, Ph.D. Associate Professor, Research Director, Program in Ethics & Policy
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 AORN Journal'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 New England Journal of Medicine, the Journal of the American Medical Association (JAMA), and the Milbank Quarterly (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.

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