Clinical Research and the Law [Paperback]
Author: Patricia M. Tereskerz | Language: English | ISBN: 1405195673 | Format: PDF, EPUB
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- 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)
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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