| 000 | 05903cam a2200673Mi 4500 | ||
|---|---|---|---|
| 001 | ocn785811678 | ||
| 003 | OCoLC | ||
| 005 | 20171115081815.0 | ||
| 006 | m o d | ||
| 007 | cr |n|---||||| | ||
| 008 | 120416s2012 nju ob 001 0 eng d | ||
| 020 |
_a9781118272152 _q(electronic bk.) |
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| 020 |
_a1118272153 _q(electronic bk.) |
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| 020 |
_a9781118272183 _q(electronic bk.) |
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| 020 |
_a1118272188 _q(electronic bk.) |
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| 020 |
_z9781405195676 _q(paper) |
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_aDEBSZ _b431125694 |
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| 035 | _a(OCoLC)785811678 | ||
| 040 |
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| 043 | _an-us--- | ||
| 049 | _aMAIN | ||
| 050 | 4 | _aR724 | |
| 072 | 7 |
_aLAW _x046000 _2bisacsh |
|
| 082 | 0 | 4 |
_a344.04 _a344.04/196 |
| 100 | 1 | _aTereskerz, Patricia M. | |
| 245 | 1 | 0 |
_aClinical research and the law / _cPatricia M. Tereskerz. _h[electronic resource] |
| 260 |
_aHoboken : _bJohn Wiley & Sons, _c2012. |
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| 300 | _a1 online resource (282 pages) | ||
| 336 |
_atext _btxt _2rdacontent |
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| 337 |
_acomputer _bc _2rdamedia |
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| 338 |
_aonline resource _bcr _2rdacarrier |
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| 504 | _aIncludes bibliographical references and index. | ||
| 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. | |
| 650 | 0 |
_aClinical medicine _xResearch. |
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| 650 | 0 |
_aClinical trials _xLaw and legislation. |
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| 650 | 4 |
_aBiomedical Research _xlegislation & jurisprudence _zUnited States. |
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| 650 | 4 |
_aBiomedical Research _xlegislation & jurisprudence. |
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| 650 | 4 |
_aBiomedical Research _xstandards _zUnited States. |
|
| 650 | 4 |
_aClinical Trials as Topic _xlegislation & jurisprudence _zUnited States. |
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| 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 |
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| 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 |
| 942 |
_2ddc _cBK |
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| 999 |
_c205825 _d205825 |
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