Clinical Research and the Law
(Sprache: Englisch)
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...
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Produktinformationen zu „Clinical Research and the Law “
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.
Klappentext zu „Clinical Research and the Law “
The legal implications of conducting clinical research and trials are becoming more complex. Everyone involved in clinical research increasingly needs to be aware of not only the ethical issues at stake but also how the law affects medical practice and research. Much of clinical research and trial law and litigation is comparatively recent and researchers need to ensure current compliance 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 discusses these topics and provides the answers to the legal questions and potential pitfalls encountered in medical research. It is an up-to-date, practical guide for clinical investigators and their institutional administrators, particularly risk managers and research administrators, as well as healthcare administrators and members of institutional review boards.
This book is also a key resource for medical students, postgraduate research students, practicing attorneys and counselors for teaching hospitals and institutions undertaking clinical research and contract research organizations.
Inhaltsverzeichnis zu „Clinical Research and the Law “
- 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
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
- Indexmed 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 Involv
Autoren-Porträt von Patricia M. Tereskerz
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.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
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Association (JAMA), and the Milbank Quarterly (See atta
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Bibliographische Angaben
- Autor: Patricia M. Tereskerz
- 2012, 1. Auflage, 280 Seiten, Maße: 13,7 x 21,4 cm, Kartoniert (TB), Englisch
- Verlag: Wiley & Sons
- ISBN-10: 1405195673
- ISBN-13: 9781405195676
Sprache:
Englisch
Rezension zu „Clinical Research and the Law “
"Clinical Research and the Law" provides thoughtful and practical information on a broad range of legal topics related to clinical research, with an emphasis on subject injury liability. The book is useful for anyone who is not an expert in a particular area of law, with numerous citations for further investigation." ( Journal of Clinical Research Best Practices , 1 October 2012)
Pressezitat
"Clinical Research and the Law" provides thoughtful and practical information on a broad range of legal topics related to clinical research, with an emphasis on subject injury liability. The book is useful for anyone who is not an expert in a particular area of law, with numerous citations for further investigation." ( Journal of Clinical Research Best Practices , 1 October 2012)Kommentar zu "Clinical Research and the Law"
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