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