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1、Chapter10EthicalGuidelinesforClinicalTrialsinMexico:TheoryandPracticeEmmaVera´steguiandEdithVa´ldez-Martı´nez110.1IntroductionThischapterexaminesseveralaspectsrelatedtoclinicaltrialsofpharmaceuticalsinMexico,includingthenumberandcharacteristicsofthetrials,the
2、irregulation,andthechallengestobeovercometoachievecompliancewithinternationalethicalstandardsandtheprotectionoftrialparticipants.Mexico,likeotherLatinAmericancountries,facesmanysocialandeconomicproblems.Expendituresonhealtharerelativelylow(6.6%oftheGrossDomes
3、ticProductin2006)(WHO2009),andthehealthsystemisfragmented,highlypoliticized,andthedemandformedicalattentionhasincreased.Althoughaccesstohealthservicesisaconstitutionalright,thereisgreatinequityinaccesstomedicalcare,andahighpercentageofthepopulationisnotableto
4、obtainneededmedications.Salariedemployeesandtheirfamilieshavegoodhealthcarecoveragethroughthevarioussocialsecurityinstitutes.AccordingtotheFederalMinistryofHealth,therestofthepopulationalmost60millionpersonshaveaccesstohealthcare1Thischapterwaswrittenin2010an
5、dsincethentherehavebeensignificantchangesinclinicaltrialregulation.COFEPRIShasimplementedaClinicalTrialRegister[REGISTRONACIONALDEENSAYOSCLI´NICOS(RNEC)]http://www.cofepris.gob.mx/AS/Paginas/Ensayos%20Cl%C3%ADnicos/Registro%20Nacional%20de%20Ensayos%20Cl%C3%AD
6、nicos%20%28RNEC%29/Registro-Nacional-de-Ensayos-Cl%C3%ADnicos-%28RNEC%29.aspx.AndtheNationalCommissionofBioethics,promotedaReformoftheLeyGeneraldeSalud,andstandardizedtheconformationofresearchethicscommitteestomeetinternationalregulations.http://www.conbioeti
7、ca-mexico.salud.gob.mx/interior/registrocomites/cei.htmlE.Vera´stegui(*)PalliativeCare,SeniorAttendingPhysician,InstitutoNacionaldeCancerologia,MexicoDF,Mexicoe-mail:everasteguia@incan.edu.mxE.Va´ldez-Martı´nezCoordinaciondeInvestigacionenSalud(enelIMSS),Inst
8、itutoMexicanodeSeguroSocial(IMSS),MexicoDF,MexicoN.HomedesandA.Ugalde(eds.),ClinicalTrialsinLatinAmerica:WhereEthics217andBusinessClash,ResearchEthicsForum2,DOI10.1007/978-3-319-01363-3_1
