03380nam 2200649 a 450 991014127080332120230801222455.01-299-31371-X1-118-27216-11-118-27215-31-118-27218-8(CKB)2670000000175282(EBL)887937(OCoLC)785811678(SSID)ssj0000633405(PQKBManifestationID)11389690(PQKBTitleCode)TC0000633405(PQKBWorkID)10617097(PQKB)10886634(MiAaPQ)EBC887937(Au-PeEL)EBL887937(CaPaEBR)ebr10630637(CaONFJC)MIL462621(EXLCZ)99267000000017528220111019d2012 uy 0engur|n|---|||||txtccrClinical research and the law[electronic resource] /Patricia M. Tereskerz ; consulting clinical editors, Robert Edelman, Ross McKinney, JrChichester, West Sussex John Wiley & Sons20121 online resource (282 p.)Description based upon print version of record.1-4051-9567-3 Includes bibliographical references and index.Research 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.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.BiologyResearchLaw and legislationUnited StatesMedicineResearchLaw and legislationUnited StatesClinical trialsLaw and legislationUnited StatesHuman experimentation in medicineLaw and legislationUnited StatesBiologyResearchLaw and legislationMedicineResearchLaw and legislationClinical trialsLaw and legislationHuman experimentation in medicineLaw and legislation344.04/196Tereskerz Patricia M992943Edelman Robert1936-1241508McKinney Ross1241509MiAaPQMiAaPQMiAaPQBOOK9910141270803321Clinical research and the law2880038UNINA