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CITI考试题MIMIC数据库
--MimicClass2HistoryandEthicsofHumanSubjectsResearch(ID498)QA
Q1:TheNationalResearchActof1974
A:EstablishedtheNationalCommission.
Q2:WhichofthefollowingbroughtincreasedpublicattentiontotheproblemswiththeIRBsystem?
A:DeathofResearchSubject(JesseGelsinger)
Q3:InformedconsentisconsideredanapplicationofwhichBelmontprinciple?
A:RespectforPersons
Q4:Issuedin1974,45CFR46raisedtoregulatorystatus:
A:USPublicHealthServicePolicy
Q5:WhichofthefollowingisincludedintheNurembergCode:
A:Voluntaryconsent
Q6:TheuseofprisonersinresearchisaconcernundertheBelmontprincipleofJusticebecause:
A:Prisonersmaynotbeusedtoconductresearchthatonlybenefitsthelargersociety
Q7:Issuedin1974,45CFR46raisedtoregulatorystatus:
A:USPublicHealthServicePolicy
Q8:WhichofthefollowingwastheresultoftheBeecherarticle?
A:RealizationthatethicalabusesarenotlimitedtotheNaziregime
--MimicClass3BasicInstitutionalReviewBoard(IRB)RegulationsandReviewProcess(ID2)QA
Q1:Asubjectinaclinicalresearchtrialexperiencesaserious,unanticipatedadversedrugexperience.Howshouldtheinvestigatorproceed,withrespecttotheIRB,afterthediscoveryoftheadverseeventoccurrence?
A:Reporttheadversedrugexperienceinatimelymanner,inkeepingwiththeIRBspoliciesandprocedures,usingtheformsorthemechanismprovidedbytheIRB.
Q2:Howlongisaninvestigatorrequiredtokeepconsentdocuments,IRBcorrespondence,andresearchrecords?
A:Foraminimumofthreeyearsaftercompletionofthestudy
Q3:Accordingtofederalregulations,whichofthefollowingbestdescribeswhenexpeditedreviewofanew,proposedstudymaybeusedbytheIRB?
A:Thestudyinvolvesnomorethanminimalriskandmeetsoneoftheallowablecategoriesofexpeditedreviewspecifiedinfederalregulations
Q4:AmendmentsinvolvingchangestoIRB-approvedprotocolsdoNOTneed
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