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More About This Title Clinical Research and the Law
English
English
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. Previously she served as Assistant Professor of Internal Medicine and Director of Health Law and Policy at the University's International Healthcare Worker Safety Center, where she was a recipient of the AORN Journal's Excellence in Research Award. Prior to joining the faculty of the Medical School, Tereskerz practiced law with Buck, Hogshire & Tereskerz, Ltd., in Charlottesville, and remains of counsel with the firm, now Buck, Toscano &Tereskerz, Ltd. Tereskerz has many publications in areas of both law and medical research, some of which have appeared in the New England Journal of Medicine, the Journal of the American Medical Association (JAMA), and the Milbank Quarterly (See attached CV). She and a colleague have recently published several articles on patent law and proposed patent reform, including two which appeared in Nature Biotechnology and another article is forthcoming in Nature Biotechnology in September. She is also author of a published handbook on needlestick injuries and the law, and is co-author of a book on the prevention and management of occupational exposure to HIV. She has served on various editorial boards.
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Preface, ix
Chapter 1: Research malpractice and negligence, 1
1.1 Background, 1
1.2 Drugs: brief description of definitions, 4
1.3 Brief overview: conduct of clinical trials, 5
1.4 Medical devices, 6
1.5 Research malpractice: the basics, 7
1.6 Negligence actions and research: interesting aspects of medical research negligence cases, 8
Chapter 2: Duty of care: understanding the legal differences between medical treatment and medical research, 23
2.1 Establishing duty of care, 23
2.2 Do sponsors have a legal duty?, 27
Chapter 3: Establishing standard of care and violation of standard of care, 33
3.1 Research malpractice and using expert testimony to establish the standard of care, 34
3.2 Lessons learned from surgical innovation cases, 35
3.3 Standard of care and informed consent cases, 36
Chapter 4: Informed consent in clinical research, 37
4.1 Basics on informed consent in the clinical treatment setting: background, 37
4.2 Informed consent as applied to the research setting, 40
4.3 Informed consent and federal regulations, 42
4.4 Case law and federal regulations, 43
4.5 Clinical trials and pediatric patients, 46
Chapter 5: Liability issues for institutional review boards (IRBs) and data safety monitoring boards (DSMBs), 55
5.1 Liability for negligence, 56
5.2 Standard of care, 57
5.3 Proximate cause and damages, 59
5.4 Defense, 60
5.5 Practical considerations: the need for indemnification, 62
5.6 Special considerations for DSMBs, 62
Chapter 6: Legal aspects of financial conflicts of interest in clinical trials, 65
6.1 Overview, 66
6.2 Legislative background: road to creating financial conflicts of interest, 68
6.3 Financial conflicts of interest: evidence that financial conflicts of interest are problematic, 69
6.4 Regulations/legislation, 70
6.5 Litigation involving financial conflicts of interest in clinical trials, 74
6.6 Applying novel legal theories to financial conflicts of interest cases, 79
6.7 Other clinical trial cases involving financial conflicts of interest claiming constitutional violations, 81
Chapter 7: Disclosure of clinical trial information: legal ramifications of withholding study results, 87
7.1 GlaxoSmithKline, 89
7.2 Vioxx and Merck, 91
7.3 Government and other clinical trial disclosure requirements, 97
7.4 Medical journal editors and disclosure of clinical trial information, 98
Chapter 8: Clinical trials and insider trading, 105
8.1 Purpose of insider trading laws, 105
8.2 Proving insider trading, 106
8.3 Penalties, 108
8.4 Insider trading cases and clinical trials, 108
8.5 Beware: investigators and relationships with the investment industry—a risk of recent vintage, 111
8.6 Setting the stage, 113
Chapter 9: Clinical trials and criminal law, 117
9.1 How clinical trial investigators have been implicated in criminal acts, 119
9.2 False Claims Act cases and health-care fraud, 120
9.3 Clinical trial False Claims Act cases, 122
9.4 Enforcement of the False Claims Act against institutions, 130
9.5 Anti-kickback law, 132
9.6 Health-care fraud, 138
9.7 Mail and wire fraud/making false statements to government officials, 141
9.8 Proposed new FDA rule, 143
Chapter 10: Clinical trial contracts, 145
10.1 Key terms/scope of study, 146
10.2 Costs/payments, 147
10.3 Data, 147
10.4 Intellectual property, 148
10.5 Indemnification/injuries, 148
10.6 Publications, 149
10.7 Various sundry provisions, 149
Appendix A: Glossary of common terms used in connection with clinical trials, 151
Appendix B: Research involving human subjects, 163
Appendix C: Best pharmaceuticals for Children Act, 173
Appendix D: Pediatric research Equity Act of 2003, 193
Appendix E: Title 21–food and drugs: additional safeguards for children in clinical investigations, 203
Appendix F: Proposed standardized/harmonized clauses for clinical trial agreements, 209
Appendix G: Responsibility of applicants for promoting objectivity in research for which public health service funding is sought and responsible prospective contractors, 225
Index, 257
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“Clinical Research and the Law” provides thoughtful and practical information on a broad range of legal topics related to clinical research, with an emphasis on subject injury liability. The book is useful for anyone who is not an expert in a particular area of law, with numerous citations for further investigation.” (Journal of Clinical Research Best Practices, 1 October 2012)
