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1、Chapter6Brazil:TheSystemfortheProtectionofVoluntaryParticipantsinResearchCorinaBontempoDucadeFreitas,WilliamSaadHossne,andSusieDutra6.1FirstStepsinResearchInvolvingHumansDiscussionsontheestablishmentofethicalparametersandtheregulationofclinicaltrialswithhumanparticipantsbeganinEuropeandtheUnitedSt
2、atesinthe1950s,gainingincreasingemphasisduringthe1970sand1980s.InBrazil,clinicalresearchgrewduringthe1980s,wheninvestigatorsfromEuropeandtheUSAinvitedmajorBraziliancenterspublichospitalsandacademiccenterstotakepartinclinicaltrials.Asaresult,the?rstcentersforresearchwereestablished,and,asinotherpar
3、tsoftheworld,someincidentshappenedwhichcausedconcernandillustratedtheneedforregulationstoprotectstudysubjects.TheNorplantstudywasamajorcaseinpoint.Norplant,along-term(?veyears)contraceptive,developedbythePopulationCounciloftheUnitedStates,consistsofsixcapsulesoflevonorgestrelinsertedbeneaththeskin
4、(IsraelandDacach1993).NorplantbegantobeusedinBrazilinthemid-1970s,butwasnotreviewedbythehealthauthoritiesuntil1984.Atthattimethecountryhadamilitarygovernment,manyuniversitieshadlinkswithpopulationcenters,andethicalstandardswerelowered.Forexample,whentheUniversityofCampinaspresentedtheNorplantproje
5、cttothehealthauthoritiesin1984,thePresidentoftheUniversitywasamemberoftheadvisorycommitteeofthePopulationCouncil,andthestudywasapprovedwithoutful?llingfundamentalethicalstandards.Thestudydidnotrequirewomentogiveinformedconsent,theC.B.D.deFreitas(*)Coordenac?aodePesquisaeComunicac?aoCient?′?ca,Fund
6、ac?aodeEnsinoePesquisaemCienciasdaSau′deFEPECS,Brasilia,Brazile-mail:corinabdf@gmail.comW.S.HossneBIOE′TICA,CentroUniversitarioSaoCamilo,SaoPaulo,BrazilS.DutraComitedeE′ticaemPesquisa,Fundac?aoHemominas,BeloHorizonte,BrazilN.HomedesandA.Ugalde(eds.),ClinicalTrialsinLatinAmerica:WhereEthics131andBu
7、sinessClash,ResearchEthicsForum2,DOI10.1007/978-3-319-01363-3_6,?SpringerInternationalPublishingSwitzerland2014132C.B.D.deFreitasetal.useoftheproductwasillegallypromotedinthemassmedia,thenumberofrecruitmentcenter
