CLINICAL RESEARCH AND THE LAW
The legal implications of conducting clinical research and trials are becoming more complex. Everyone involved in clinical research increasingly needs to be aware of not only the ethical issues at stake but also how the law affects medical practice and research. Much of clinical research and trial law and litigation is comparatively recent and researchers need to ensure current compliance on a wide range of issues including:standards and duty of careconflicts of interestestablishing clinical trialsinformed consentresearch contractsthe disclosure and withholding of clinical trial results
Clinical Research and the Law comprehensively discusses these topics and provides the answers to the legal questions and potential pitfalls encountered in medical research. It is an up-to-date, practical guide for clinical investigators and their institutional administrators, particularly risk managers and research administrators, as well as healthcare administrators and members of institutional review boards.
This book is also a key resource for medical students, postgraduate research students, practicing attorneys and counselors for teaching hospitals and institutions undertaking clinical research and contract research organizations.
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 industrya 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 21food 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
