05903cam a2200673Mi 4500 ocn785811678 OCoLC 20171115081815.0 m o d cr |n|---||||| 120416s2012 nju ob 001 0 eng d 9781118272152 (electronic bk.) 1118272153 (electronic bk.) 9781118272183 (electronic bk.) 1118272188 (electronic bk.) 9781405195676 (paper) DEBSZ 431125694 NZ1 15900629 DEBBG BV043394464 (OCoLC)785811678 EBLCP eng pn EBLCP OCLCQ N$T OCLCQ YDXCP OCLCO CUS DG1 OCLCQ OHI OCLCF OCLCQ DEBSZ OCLCQ COO OCLCQ DEBBG n-us--- MAIN R724 LAW 046000 bisacsh 344.04 344.04/196 Tereskerz, Patricia M. Clinical research and the law / Patricia M. Tereskerz. [electronic resource] Hoboken : John Wiley & Sons, 2012. 1 online resource (282 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Includes bibliographical references and index. Clinical Research and the Law; Contents; Preface; Chapter 1: Research malpractice and negligence; 1.1 Background; 1.2 Drugs: brief description of definitions; 1.3 Brief overview: conduct of clinical trials; 1.4 Medical devices; 1.5 Research malpractice: the basics; 1.6 Negligence actions and research: interesting aspects of medical research negligence cases; Chapter 2: Duty of care: understanding the legal differences between medical treatment and medical research; 2.1 Establishing duty of care; 2.2 Do sponsors have a legal duty? Chapter 3: Establishing standard of care and violation of standard of care; 3.1 Research malpractice and using expert testimony to establish the standard of care; 3.2 Lessons learned from surgical innovation cases; 3.3 Standard of care and informed consent cases; Chapter 4: Informed consent in clinical research; 4.1 Basics on informed consent in the clinical treatment setting: background; 4.2 Informed consent as applied to the research setting; 4.3 Informed consent and federal regulations; 4.4 Case law and federal regulations; 4.5 Clinical trials and pediatric patients. Chapter 5: Liability issues for institutional review boards (IRBs) and data safety monitoring boards (DSMBs); 5.1 Liability for negligence; 5.2 Standard of care; 5.3 Proximate cause and damages; 5.4 Defense; 5.5 Practical considerations: the need for indemnification; 5.6 Special considerations for DSMBs; Chapter 6: Legal aspects of financial conflicts of interest in clinical trials; 6.1 Overview; 6.2 Legislative background: road to creating financial conflicts of interest; 6.3 Financial conflicts of interest: evidence that financial conflicts of interest are problematic. 6.4 Regulations/legislation; 6.5 Litigation involving financial conflicts of interest in clinical trials; 6.6 Applying novel legal theories to financial conflicts of interest cases; 6.7 Other clinical trial cases involving financial conflicts of interest claiming constitutional violations; Chapter 7: Disclosure of clinical trial information: legal ramifications of withholding study results; 7.1 GlaxoSmithKline; 7.2 Vioxx and Merck; 7.3 Government and other clinical trial disclosure requirements; 7.4 Medical journal editors and disclosure of clinical trial information. Chapter 8: Clinical trials and insider trading; 8.1 Purpose of insider trading laws; 8.2 Proving insider trading; 8.3 Penalties; 8.4 Insider trading cases and clinical trials; 8.5 Beware: investigators and relationships with the investment industry--a risk of recent vintage; 8.6 Setting the stage; Chapter 9: Clinical trials and criminal law; 9.1 How clinical trial investigators have been implicated in criminal acts; 9.2 False Claims Act cases and health-care fraud; 9.3 Clinical trial False Claims Act cases; 9.4 Enforcement of the False Claims Act against institutions; 9.5 Anti-kickback law. 9.6 Health-care fraud. 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. Print version record. Clinical medicine Research. Clinical trials Law and legislation. Biomedical Research legislation & jurisprudence United States. Biomedical Research legislation & jurisprudence. Biomedical Research standards United States. Clinical Trials as Topic legislation & jurisprudence United States. Clinical Trials as Topic standards United States. Medicine. Law. LAW Health. bisacsh Clinical medicine Research. fast (OCoLC)fst00864379 Clinical trials Law and legislation. fast (OCoLC)fst00864434 Electronic books. Print version: Tereskerz, Patricia M. Clinical Research and the Law. Hoboken : John Wiley & Sons, ©2012 9781405195676 http://onlinelibrary.wiley.com/book/10.1002/9781118272152 Wiley Online Library ddc BK 205825 205825