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008 120416s2012 nju ob 001 0 eng d
040 _aEBLCP
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020 _a9781118272152
_q(electronic bk.)
020 _a1118272153
_q(electronic bk.)
020 _a9781118272183
_q(electronic bk.)
020 _a1118272188
_q(electronic bk.)
020 _z9781405195676
_q(paper)
029 1 _aDEBSZ
_b431125694
029 1 _aNZ1
_b15900629
029 1 _aDEBBG
_bBV043394464
035 _a(OCoLC)785811678
043 _an-us---
050 4 _aR724
072 7 _aLAW
_x046000
_2bisacsh
082 0 4 _a344.04
_a344.04/196
049 _aMAIN
100 1 _aTereskerz, Patricia M.
245 1 0 _aClinical research and the law /
_cPatricia M. Tereskerz.
260 _aHoboken :
_bJohn Wiley & Sons,
_c2012.
300 _a1 online resource (282 pages)
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
505 0 _aClinical 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?
505 8 _aChapter 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.
505 8 _aChapter 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.
505 8 _a6.4 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.
505 8 _aChapter 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.
505 8 _a9.6 Health-care fraud.
520 _aThis 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.
588 0 _aPrint version record.
504 _aIncludes bibliographical references and index.
650 0 _aClinical medicine
_xResearch.
650 0 _aClinical trials
_xLaw and legislation.
650 4 _aBiomedical Research
_xlegislation & jurisprudence
_zUnited States.
650 4 _aBiomedical Research
_xlegislation & jurisprudence.
650 4 _aBiomedical Research
_xstandards
_zUnited States.
650 4 _aClinical Trials as Topic
_xlegislation & jurisprudence
_zUnited States.
650 4 _aClinical Trials as Topic
_xstandards
_zUnited States.
650 4 _aMedicine.
650 4 _aLaw.
650 7 _aLAW
_xHealth.
_2bisacsh
650 7 _aClinical medicine
_xResearch.
_2fast
_0(OCoLC)fst00864379
650 7 _aClinical trials
_xLaw and legislation.
_2fast
_0(OCoLC)fst00864434
655 4 _aElectronic books.
776 0 8 _iPrint version:
_aTereskerz, Patricia M.
_tClinical Research and the Law.
_dHoboken : John Wiley & Sons, ©2012
_z9781405195676
856 4 0 _uhttp://onlinelibrary.wiley.com/book/10.1002/9781118272152
_zWiley Online Library [Free Download only for SUST IP]
938 _aEBL - Ebook Library
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_nEBL887937
938 _aEBSCOhost
_bEBSC
_n446162
938 _aYBP Library Services
_bYANK
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938 _aYBP Library Services
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