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Vol 21 No 11 Nov/Dec 2016

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Clinical Research and the Law

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ISBN13: 9781405195676
Published: May 2012
Publisher: Wiley-Blackwell
Country of Publication: USA
Format: Paperback
Price: £52.50



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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.

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Subjects:
Medical Law
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 Actp>
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