Clinical Research and the Law

ISBN: 9781405195676 出版年：2012 页码：282 Patricia M Tereskerz Wiley

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