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1、Chapter1IntroductionNuriaHomedesandAntonioUgalde1.1TheOriginsandDevelopmentofThisProjectThetensionbetweentheneedtodevelopbettertreatmentsandprotecthumanresearchparticipantsisparticularlyacuteinlowandmiddleincomecountries,wherethenumberofclinicaltrialswithpharmaceuticalsisontherise
2、andthesystemstoprotecttheresearchparticipantsarerelativelynewandtendtobepoorlydevel-oped.While,LatinAmericanvolunteershavebeenparticipatingininternationalresearchandinclinicaltrialssincethebeginningofthetwentiethcentury,mostLatinAmericancountriesdidnothaveregulatoryagenciesoraregu
3、latoryframeworkguidingtheimplementationofclinicalresearchuntilthemid-1990sorearly2000s.AseditorsofanelectronicbulletinaimedatimprovingtheuseofpharmaceuticalsamongtheSpanish-speakingpopulations(www.saludyfarmacos.org),theeditorsofthiscollectionbecameawareofreportsdescribingviolatio
4、nsofethicalresearchprinciplesinCostaRicaandArgentina(Vargas2006;Orchuela2006a,b).Later,duringmeetingsinPeru,CostaRicaandArgentinawelearnedthatColombianresearchparticipantsdidnotunderstandtheconceptofinformedconsent;Argentineanpsychiatricpatientshadbeenincludedinresearchprojectswit
5、houtobtainingtheinformedconsentfromguardiansor,intheirabsence,fromthejudiciary;andconcernedCostaRicanshadunveiledproblemswithaverylargeclinicaltrial(over13,000participants)tostudytheeffectivenessofavaccineagainsthumanpapillomavirus.Ethicalresearchconcernsarecommonthrough-outthewor
6、ld,butwhatwasstrikingaboutthesituationinLatinAmericawastheinsularityofthebioethicistsandconcernedresearchersthatwereunveilingtheseissues.Researchersinothercountriesdidnotknowaboutanyofthecasesdescribedabove.N.Homedes(*)SchoolofPublicHealth,DivisionofManagementPolicyandCommunityHea
7、lth,UniversityofTexasHoustonHealthScienceCenter,ElPaso,TX,USAe-mail:nhomedes@utep.eduA.UgaldeDepartmentofSociology,UniversityofTexas,Austin,TX,USAe-mail:augalde@utexas.eduN.HomedesandA.Ugalde(eds.),ClinicalTrialsinLatinAmerica:WhereEthics1andBusinessClash,ResearchEthicsForum2,DOI1
8、0.1007/978-3-319-01363-3_1,©Sprin
