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1、Chapter5PoliticsandClinicalTrialsintheProvinceofCordobaAntonioUgaldeandNuriaHomedes5.1TheClinicalTrialRegulatoryFrameworkinCordobaAsexplainedinChap.4,Argentinaisafederationof23provincesandtheautonomousFederalCapital.Eachprovincehasitsownexecutive,legisl
2、ative,andjudicialgovernments.EachprovincehasitsownMinistryofHealththatisresponsiblefortheregulationofthehealthsectorandtheprovisionofmedicalcareservicesforthepoor.ItisestimatedthatonethirdofallclinicaltrialsconductedinthecountrytakeplaceintheProvinceofC
3、ordoba,whichhousesaboutonetenthofthenationalpopulation(Ferna´ndez2005a).Recognizingthissituation,theprovincialgovern-mentinitiatedthedevelopmentofstandardsforclinicalresearchinvolvinghumans.In2001,thebioethicsdepartmentoftheprovincialMinistryofHealthdes
4、ignedaprogramforethicsinhealthresearch,whichincludedthecreationofaProvincialCommissionforEthicsinHealthResearch(COPEISinSpanish)todevelopethicalstandards,trainprofessionalsinresearchethics,establishcriteriaforaccreditationofInstitutionalResearchEthicsCo
5、mmittees(IRECs),createaProvincialRegistryforHealthResearch(RHR),andevaluateresearchprotocolsthatcouldthreatenthewellbeingofclinicaltrialparticipants.Duringthefirsttwoyears(2001and2002),almost200professionalsweretrainedinfive-monthclassroomcourses.TheCOPEI
6、Sstartedfunctioningin2002aspartofasupervisionunitoftheprovincialMinistryofPublicHealth,astatusthatTheauthorswouldliketothankJuanCarlosTealdiandSusanaVidalfortheirassistanceandcommentsduringthepreparationofthischapter.Theauthorshavesoleresponsibilityfora
7、nalysisandinterpretationofthedata.A.UgaldeDepartmentofSociology,UniversityofTexas,Austin,TX,USAN.Homedes(*)SchoolofPublicHealth,DivisionofManagementPolicyandCommunityHealth,UniversityofTexasHoustonHealthScienceCenter,ElPaso,TX,USAe-mail:nhomedes@utep.ed
8、uN.HomedesandA.Ugalde(eds.),ClinicalTrialsinLatinAmerica:WhereEthics113andBusinessClash,ResearchEthicsForum2,DOI10.1007/978-3-319-01363-3_5,©SpringerInternationalPublishingSwitzerland2014114A.UgaldeandN.Homedesgaveitlegitimacyand
