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The following ISBNs are associated with this title:
ISBN - 10:1405195673
ISBN - 13:9781405195676
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Table of Contents
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