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Preface | |
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Research malpractice and negligence | |
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Background | |
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Drugs: brief description of definitions | |
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Brief overview: conduct of clinical trials | |
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Medical devices | |
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Research malpractice: the basics | |
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Negligence actions and research: interesting aspects of medical research negligence cases | |
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Duty of care: understanding the legal differences between medical treatment and medical research | |
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Establishing duty of care | |
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Do sponsors have a legal duty? | |
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Establishing standard of care and violation of standard of care | |
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Research malpractice and using expert testimony to establish the standard of care | |
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Lessons learned from surgical innovation cases | |
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Standard of care and informed consent cases | |
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Informed consent in clinical research | |
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Basics on informed consent in the clinical treatment setting: background | |
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Informed consent as applied to the research setting | |
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Informed consent and federal regulations | |
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Case law and federal regulations | |
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Clinical trials and pediatric patients | |
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Liability issues for institutional review boards (IRBs) and data safety monitoring boards (DSMBs) | |
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Liability for negligence | |
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Standard of care | |
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Proximate cause and damages | |
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Defense | |
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Practical considerations: the need for indemnification | |
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Special considerations for DSMBs | |
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Legal aspects of financial conflicts of interest in clinical trials | |
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Overview | |
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Legislative background: road to creating financial conflicts of interest | |
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Financial conflicts of interest: evidence that financial conflicts of interest are problematic | |
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Regulations/legislation | |
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Litigation involving financial conflicts of interest in clinical trials | |
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Applying novel legal theories to financial conflicts of interest cases | |
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Other clinical trial cases involving financial conflicts of interest claiming constitutional violations | |
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Disclosure of clinical trial information: legal ramifications of withholding study results | |
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GlaxoSmithKline | |
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Vioxx and Merck | |
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Government and other clinical trial disclosure requirements | |
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Medical journal editors and disclosure of clinical trial information | |
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Clinical trials and insider trading | |
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Purpose of insider trading laws | |
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Proving insider trading | |
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Penalties | |
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Insider trading cases and clinical trials | |
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Beware: investigators and relationships with the investment industry-a risk of recent vintage | |
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Setting the stage | |
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Clinical trials and criminal law | |
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How clinical trial investigators have been implicated in criminal acts | |
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False Claims Act cases and health-care fraud | |
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Clinical trial False Claims Act cases | |
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Enforcement of the False Claims Act against institutions | |
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Anti-kickback law | |
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Health-care fraud | |
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Mail and wire fraud/making false statements to government officials | |
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Proposed new FDA rule | |
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Clinical trial contracts | |
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Key terms/scope of study | |
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Costs/payments | |
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Data | |
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Intellectual property | |
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Indemnification/injuries | |
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Publications | |
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Various sundry provisions | |
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Glossary of common terms used in connection with clinical trials | |
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Research involving human subjects | |
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Best pharmaceuticals for Children Act | |
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Pediatric research Equity Act of 2003 | |
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Title 21-food and drugs: additional safeguards for children in clinical investigations | |
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Proposed standardized/harmonized clauses for clinical trial agreements | |
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Responsibility of applicants for promoting objectivity in research for which public health service funding is sought and responsible prospective contractors | |
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Index | |