Clinical Research and the Law by Patricia M. TereskerzClinical Research and the Law by Patricia M. Tereskerz

Clinical Research and the Law

byPatricia M. Tereskerz

Paperback | May 7, 2012

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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.
Patricia M. Tereskerz, JD, Ph.D. Associate Professor, Research Director, Program in Ethics & Policy Patti Tereskerz joined the University of Virginia Center for Biomedical Ethics in the fall of 2001. She is Director of the Program in Ethics and Policy at the Center and chairs the Conflicts of Interest Committee for the University. Prev...
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Title:Clinical Research and the LawFormat:PaperbackDimensions:280 pages, 8.5 × 5.5 × 0.55 inPublished:May 7, 2012Publisher:WileyLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:1405195673

ISBN - 13:9781405195676

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Table of 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