Patricia M. Tereskerz

Clinical Research and the Law

• Broschiertes Buch

Produktbeschreibung

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.

Produktdetails

• Verlag: Wiley & Sons
• Artikelnr. des Verlages: 1A405195670
• 1. Auflage
• Seitenzahl: 288
• Erscheinungstermin: 7. Mai 2012
• Englisch
• Abmessung: 216mm x 140mm x 15mm
• Gewicht: 359g
• ISBN-13: 9781405195676
• ISBN-10: 1405195673
• Artikelnr.: 35046671

Autorenporträt

Patricia M. Tereskerz Associate Professor and Director, Program in Ethics and Policy in Healthcare, Center for Biomedical Ethics and Humanities, University of Virginia School of Medicine, Charlottesville, VA, USA

Inhaltsangabe

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