Monday, March 3, 2014

Clinical Research and the Law


Clinical Research and the Law [Paperback]

Author: Patricia M. Tereskerz | Language: English | ISBN: 1405195673 | Format: PDF, EPUB

Clinical Research and the Law
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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.
Download latest books on mediafire and other links compilation Clinical Research and the Law [Paperback]
  • Paperback: 280 pages
  • Publisher: Wiley-Blackwell; 1 edition (May 7, 2012)
  • Language: English
  • ISBN-10: 1405195673
  • ISBN-13: 978-1405195676
  • Product Dimensions: 0.6 x 5.5 x 8.5 inches
  • Shipping Weight: 11.4 ounces (View shipping rates and policies)
  • Amazon Best Sellers Rank: #1,412,817 in Books (See Top 100 in Books)
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

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