Patricia M. (Associate Professor, Research Director, Program in Ethics and Policy, University of Virginia Center for Biomedical Ethics, Charlottesville, US) Tereskerz
Meer over de auteurs
Patricia M. (Associate Professor, Research Director, Program in Ethics and Policy, University of Virginia Center for Biomedical Ethics, Charlottesville, US) Tereskerz,
PM Tereskerz
John Wiley & Sons
e druk, 2012
9781405195676
Clinical Research and the Law
Specificaties
Paperback, 280 blz.
|
Engels
John Wiley & Sons |
e druk, 2012
ISBN13: 9781405195676
Rubricering
Juridisch
:
Verwachte levertijd ongeveer 9 werkdagen
Samenvatting
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.
Specificaties
Inhoudsopgave
Preface
<p>Chapter One: Research Malpractice & Negligence</p>
<p>Chapter Two: Duty of Care: Understanding the Legal</p>
<p>Differences Between Medical Treatment and Medical Research</p>
<p>Chapter Three: Establishing Standard of Care & Violation of Standard of Care</p>
<p>Chapter Four: Informed Consent in Clinical Research</p>
<p>Chapter Five: Liability Issues for Institutional Review</p>
<p>Boards (IRB s) and Data Safety Monitoring Boards (DSMB s)</p>
<p>Chapter Six: Legal Aspects of Financial Conflicts of Interest in Clinical Trials</p>
<p>Chapter Seven: Disclosure of Clinical Trial Information: Legal Ramifications of Withholding Study Results</p>
<p>Chapter Eight: Clinical Trials & Insider Trading</p>
<p>Chapter Nine: Clinical Trials and Criminal Law</p>
<p>Chapter Ten: Clinical Trial Contracts</p>
<p>Appendix A Glossary</p>
<p>Appendix B NIH Policy on Inclusion of Children as Participants in Research Involving Human Subjects</p>
<p>Appendix C Best Pharmaceuticals for Children Act p>Appendix D Pediatric Research Equity Act 2003</p>
<p>Appendix E Code of Federal Regulations Title 21</p>
<p>Appendix F NCI model contract</p>
<p>Appendix G Conflicts of Interest</p>
<p>Index</p>
<p>Chapter One: Research Malpractice & Negligence</p>
<p>Chapter Two: Duty of Care: Understanding the Legal</p>
<p>Differences Between Medical Treatment and Medical Research</p>
<p>Chapter Three: Establishing Standard of Care & Violation of Standard of Care</p>
<p>Chapter Four: Informed Consent in Clinical Research</p>
<p>Chapter Five: Liability Issues for Institutional Review</p>
<p>Boards (IRB s) and Data Safety Monitoring Boards (DSMB s)</p>
<p>Chapter Six: Legal Aspects of Financial Conflicts of Interest in Clinical Trials</p>
<p>Chapter Seven: Disclosure of Clinical Trial Information: Legal Ramifications of Withholding Study Results</p>
<p>Chapter Eight: Clinical Trials & Insider Trading</p>
<p>Chapter Nine: Clinical Trials and Criminal Law</p>
<p>Chapter Ten: Clinical Trial Contracts</p>
<p>Appendix A Glossary</p>
<p>Appendix B NIH Policy on Inclusion of Children as Participants in Research Involving Human Subjects</p>
<p>Appendix C Best Pharmaceuticals for Children Act p>Appendix D Pediatric Research Equity Act 2003</p>
<p>Appendix E Code of Federal Regulations Title 21</p>
<p>Appendix F NCI model contract</p>
<p>Appendix G Conflicts of Interest</p>
<p>Index</p>
Net verschenen
Rubrieken
- aanbestedingsrecht
- aansprakelijkheids- en verzekeringsrecht
- accountancy
- algemeen juridisch
- arbeidsrecht
- bank- en effectenrecht
- bestuursrecht
- bouwrecht
- burgerlijk recht en procesrecht
- europees-internationaal recht
- fiscaal recht
- gezondheidsrecht
- insolventierecht
- intellectuele eigendom en ict-recht
- management
- mens en maatschappij
- milieu- en omgevingsrecht
- notarieel recht
- ondernemingsrecht
- pensioenrecht
- personen- en familierecht
- sociale zekerheidsrecht
- staatsrecht
- strafrecht en criminologie
- vastgoed- en huurrecht
- vreemdelingenrecht
