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1、Chapter12AViewfromInside:RegulationandEthicalConflictsinPeruGabrielaE.Minaya-Martı´nez,SusyY.Olave-Quispe,andDuilioJ.Fuentes-Delgado12.1IntroductionAfteradiscussionontheevolutionofclinicaltrialsinPeru,thischapterreviewsthedevelopmentoflegislationgoverningclinicaltrialsandtheethical
2、problemsthathaveoccurredduringtheirimplementation.Peru(population29.2millionin2009)isamulti-ethnicandpredominantlyurban(72%)country(WorldPopulationData2009).Ithasayoungpopulationwith32%below15yearsofageandonly6%olderthan65years.In2010,thepopulationover15yearsofagehadanilliteracyra
3、teof7.4%andanaverageof9yearsofeducation.Therearenoreliablestatisticsforfunctionalilliteracy,butitisasafeassumptionthatthemajorityoftheadultpopulationfallsintothiscategory.Althoughdeclining,theratesofpeopleinpovertyandextremepovertyremainhigh-at45and16%respectively.Inequalitylevels
4、arealsohighwithaGiniindexofwealthdistributionof0.51.PovertyindexesamongtheAndean,theAmazonianandCostalregionsPerusthreedistinctgeographicareas,eachwithitsownclimateandculturesare64,57,and29%respectively(INEI20042006).Nationally,lifeexpectancyis72years,infantmortalityis20per1,000li
5、vebirths,andmaternalmortality,15per100,000livebirths(INEI2008).Themorbi-mortalitydatainthecountryreflectasocietyintransitionwithanincreaseinchronicconditionsco-existingwitharelativelyhighrateoftransmissiblediseases.Forexample,mortalityratesforcardiovasculardiseasesandcancerare190an
6、d175per100,000respectively(WHO2007).Amongchildrenunderfiveyearsofage,25%sufferwithchronicmalnutrition,andwithinthisagegroupthereare240episodesofacutediarrheaandG.E.Minaya-Martı´nez(*)D.J.Fuentes-DelgadoLaOficinaGeneraldeInvestigacio´nyTransferenciaTecnolo´gica(OGITT),InstitutoNacion
7、aldeSaludofPeru´,Lima,Perue-mail:gminayam@gmail.comS.Y.Olave-QuispeUnitofExecutiveSupport,Divisio´ndeasuntosinternacionalesydelaUnio´nEuropea,AgenciaEspanoladeMedicamentosyProductosSanitarios,Madrid,SpainN.HomedesandA.Ugalde(eds.),ClinicalTrialsinLatinAmerica:WhereEthics251andBusi
8、nessClash,ResearchEthicsForum2,DO