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Clinical Research and the Law by Patricia M. Tereskerz (2012, Trade Paperback)

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About this product

Product Identifiers

PublisherWiley & Sons, Incorporated, John

ISBN-101405195673

ISBN-139781405195676

eBay Product ID (ePID)127347904

Product Key Features

Number of Pages288 Pages

Publication NameClinical Research and the Law

LanguageEnglish

Publication Year2012

SubjectEthics, Life Sciences / Biology

TypeTextbook

Subject AreaScience, Medical

AuthorPatricia M. Tereskerz

FormatTrade Paperback

Dimensions

Item Height0.6 in

Item Weight10.8 Oz

Item Length8.5 in

Item Width5.5 in

Additional Product Features

Intended AudienceScholarly & Professional

LCCN2011-043554

Reviews"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)

Dewey Edition23

Dewey Decimal344.04/196

Table Of ContentPreface, 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

SynopsisThe 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 care informed consent conflicts of interest research contracts establishing clinical trials the 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., This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research., 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., 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 care conflicts of interest establishing clinical trials informed consent research contracts the 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.

LC Classification NumberW 33 AA1