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100   $a20111019d2012      uy             0
101 0 $aeng
135   $aur|n|---|||||
181   $ctxt
182   $cc
183   $acr
200 10$aClinical research and the law$b[electronic resource] /$fPatricia M. Tereskerz ; consulting clinical editors, Robert Edelman, Ross McKinney, Jr
210   $aChichester, West Sussex $cJohn Wiley & Sons$d2012
215   $a1 online resource (282 p.)
300   $aDescription based upon print version of record.
311   $a1-4051-9567-3 
320   $aIncludes bibliographical references and index.
327   $aResearch malpractice & negligence -- Duty of care : understanding the legal differences between medical treatment and medical research -- Establishing standard of care & violation of standard of care -- Informed consent in clinical research -- Liability issues for institutional review boards (IRBs) and data safety monitoring boards (DSMBs) -- Legal aspects of financial conflicts of interest in clinical trials -- Disclosure of clinical trial information : legal ramifications of withholding study results -- Clinical trials & insider trading -- Clinical trials and criminal law -- Clinical trial contracts.
330   $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.
606   $aBiology$xResearch$xLaw and legislation$zUnited States
606   $aMedicine$xResearch$xLaw and legislation$zUnited States
606   $aClinical trials$xLaw and legislation$zUnited States
606   $aHuman experimentation in medicine$xLaw and legislation$zUnited States
615  0$aBiology$xResearch$xLaw and legislation
615  0$aMedicine$xResearch$xLaw and legislation
615  0$aClinical trials$xLaw and legislation
615  0$aHuman experimentation in medicine$xLaw and legislation
676   $a344.04/196
700   $aTereskerz$b Patricia M$0992943
701   $aEdelman$b Robert$f1936-$01241508
701   $aMcKinney$b Ross$01241509
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910141270803321
996   $aClinical research and the law$92880038
997   $aUNINA