Main description:

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.

Contents:

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