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ACRP – CP Exam (Latest 2024 – 2025) With Complete Solution
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ACRP – CP Exam (Latest 2024 – 2025) With Complete Solution
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ACRP – CP Exam (Latest 2024 – 2025)With Complete Solution
BelmontsReports(1979)s-
sethicalsprinciplessandsguidelinessforsthesprotectionsofshumanssubjectssofsresearch.
respectsforspersonss-
sindividualssshouldsbestreatedsassautonomoussagentssandspersonsswithsdiminishedsautonom
ysaresentitledstosprotection
Ansautonomousspersons-
sAspersonscapablesofsdeliberationsaboutspersonalsgoalssandsofsactingsundersthesdirectionsofss
uchsdeliberation
Beneficences-sDosnotsharmsandsmaximizespossiblesbenefitssandsminimizespossiblesharms
Justices-
s1)stoseachspersonsansequalsshares2)stoseachspersonsaccordingstosindividualsneeds3)stoseachs
personsaccordingstosindividualsefforts4)stoseachspersonsaccordingstossocietalscontributionss5
)stoseachspersonsaccordingstosmerit
Justices-
s·sThesselectionsofsresearchssubjectssneedsstosbesscrutinizedsinsorderstosdetermineswhethers
somesclassessaresbeingssystematicallysselectedssimplysbecausesofstheirseasysavailability,sthei
rscompromisedsposition,sorstheirsmanipulability,srathersthansforsreasonssdirectlysrelatedstos
thesproblemsbeingsstudied.
Justices-
s·sWheneversresearchssupportedsbyspublicsfundssleadsstosthesdevelopmentsofstherapeuticsde
vicessandsprocedures,sjusticesdemandssbothsthatsthesesnotsprovidesadvantagessonlystosthose
swhoscansaffordsthemsandsthatssuchsresearchsshouldsnotsundulysinvolvespersonssfromsgroup
ssunlikelystosbesamongsthesbeneficiariessofssubsequentsapplicationssofsthesresearch.
Threeselementssofsthesconsentsprocesss-sinformation,scomprehension,svoluntariness
Whatsissansexamplesofshowsthesprinciplesofsbeneficencescansbesappliedstosasstudysemploying
shumanssubjectss-
sDeterminingsthesstudyshassasmaximizationsofsbenefitssandsasminimizationsofsrisks
WhatsaresthesthreesprinciplessdiscussedsinsthesBelmontsReport?s-
sRespectsforspersons,sbeneficence,sjustice
,ThesBelmontsReport'ssprinciplesofsrespectsforspersonssincorporatessatsleasts2sethicalsconvict
ions:sfirst,sthatsindividualssshouldsbestreatedsassautonomoussagents,sandssecond,sthat:s-
sPersonsswithsdiminishedsautonomysaresentitledstosprotection
NurembergsCodes(1947)s-
s1)sasrequirementssforsvoluntarysconsents2)sthesresearchsmustshavesscientificsmerits3)sThesb
enefitssofsthesresearchsmustsoutweighsthesriskss4)sSubjectsshavesthesabilitystosterminatespar
ticipationsinsthesresearchsatsanystime
NationalsResearchsActs(1974)s-
s1)sAuthorizedsthescreationsofsthesNationalsCommissionsforsthesProtectionsofsHumansSubject
ssofsBiomedicalsandsBehavioralsResearch,swhichswasschargedswithsdevelopingsansethicalscod
esandsguidelinessforsresearcherss2)sRequiredsthesestablishmentsofsIRBssatsorganizationssrec
eivingsPHSssupportsforshumanssubject'ssresearch
ThesNationalsCommissions(1975-1978s-
sIssuedsasseriessofsreportssonsvulnerablespopulationss(suchsassfetuses,schildren,sprisoners,sa
ndsthes"mentallysinfirm")spsychosurgery,sIRBs,sandsotherstopicssthatsincludedsrecommenda
tionssforsregulatingshumanssubjects'sresearch.sThesesrecommendationsshadssignificantsinflu
encesonsthesdevelopmentsofsthesfederalsregulationssgoverningshumanssubjectsresearch.
45sCFRs46s-
sAlsosknownsassthesCommonsRule,sthisslegislationsestablishedsthesrolesofsinstitutionalsrevie
wsboardss(IRBs)sforsresearchsonshumansrights.
Additionalsprotectionsforsthesesindividualssinsresearchs-
s1)spregnantswomen,shumansfetuses,sandsneonatess2)schildrens3)sprisoners
21sCFRs50s-sInformedsConsent
21sCFRs56s-sIRB
21sCFRs812s-sInvestigationalsMedicalsDevices
21sCFRs312s-sInvestigationalsDrugssandsBiologics
DeclarationsofsHelsinkis(1964)s-
sRecommendationssguidingsmedicalsdoctorssinsbiomedicalsresearchsinvolvingshumanssubjec
ts
WHOsGuideliness(1996)sStandardssandsOperationalsGuidancesforsEthicssReviewsofsHealth-
relatedsResearchswithsHumansParticipants"s-
sDocumentssdesignedstosservesassinternationalsguidelinessforsthesreviewsandsconductsofsres
earchsinvolvingshumanssubjects
ICHsE6s-sGuidelinesforsGoodsClinicalsPractice
,ThesusesofsprisonerssinsresearchsissasconcernsundersthesBelmontsprinciplesforsJusticesbecaus
e:s-sPrisonerssmaysnotsbesusedstosconductsresearchsthatsonlysbenefitsstheslargerssociety
WhatswassthesresultsofsthesBeechersarticle?s-
sRealizationsthatsethicalsabusessaresnotslimitedstosthesNazisregime
Issuedsins1974,s45sCFRs46sraisedstosregulatorysstatus:s-sUSsPublicsHealthsServicesPolicy
WhatsissincludedsinsthesNurembergsCode?s-sInformedsconsent
InformedsconsentsissconsideredsansapplicationsofswhichsBelmontsprinciple?s-
sRespectsforspersons
IRBs(InstitutionalsReviewsBoard)s-
sAsreviewscommitteesestablishedstoshelpsprotectsthesrightssandswelfaresofshumansresearchss
ubjects
Regulationssrequire:s-
sIRBsreviewsandsapprovalsforsresearchsinvolvingshumanssubjectssifsitsissconducted,ssupporte
d,sorsregulatedsbysUSsfederalsdepartmentssandsagencies
FederalsregulationssstipulatesthatsansIRBscan:s-
sApprovesresearch,srequiresmodifications,sdisapprovesresearch,sconductscontinuingsreviews
,sverifysnosmaterialschangessoccurredssincesprevioussreview,sobserve,ssuspend/terminatesa
pproval
Conveyedscommitteesreviews-
sFullscommitteesreview.sStandardstypesofsreviewsdescribedsinsthesfederalsregulations.sMusts
besusedsforsthesinitialsreviewsofsallsstudiessthatsaresnotseligiblesforsexpeditedsreviewsorsexe
mption
Expeditedsreviews-
sCansbesusedsforsestablishedscategoriessandsminorschangessinspreviouslysapprovedsresearch,
sandsforslimitedsIRBsreviewsofsselectsexemptionscategories
Categoriessforsexpeditedsreview:s-s1)sThesresearchsdoessnotsinvolvesmoresthansminimalsrisks
2)sThesentiresresearchsprojectsmustsbesconsistentswithsonesorsmoresofsthesfederallysdefineds
categoriess(IND/IDEsnotesrequired)
TypessofsIRBssubmissionss-s1)sApplicationsforsinitialsreviews
2)sApplicationsforscontinuingsreview:sIRBsmustsre-
reviewsgreatersthansminimalsrisksnotslesssthansoncespersyears
3)sAmendmentssorsmodifications
4)sReportssofsunanticipatedsproblems
, USsDepartmentsofsHealthsandsHumansServicess-sResponsiblesfors45sCFRs46
NationalsInstitutessofsHealths(NIH)s-
sIncludessfundingsagenciessthatsprovidesfederalsfundingsforsbiomedicalsresearch
U.S.sFoodsandsDrugsAdministrations(FDA)s-
sOverseessthesusesofsallsdrugs,sdevices,sbiologics,setc.sincludingstheirsusesinsresearchswithshu
manssubjects
InternationalsCouncilsforsHarmonisations(ICH)s-sofferssGPsguidelines
Assubjectsinsasclinicalsresearchstrialsexperiencessasserious,sunanticipatedsadversesdrugsexper
ience.sHowsshouldsthesinvestigatorsproceed,swithsrespectstosthesIRB,saftersthesdiscoverysofst
hesadverseseventsoccurrence?s-
sReportsthesadversesdrugsexperiencesinsastimelysmanner,sinskeepingswithsthesIRB'sspoliciessa
ndsprocedures,susingsthesformssorsthesmechanismsprovidedsbysthesIRB
Howslongsissansinvestigatorsrequiredstoskeepsconsentsdocuments,sIRBscorrespondence,sands
researchsrecords?s-sAsminimumsofsthreesyearssafterscompletionsofsthesstudy
Accordingstosfederalsregulations,swhichsofsthesfollowingsbestsdescribesswhensexpeditedsrevi
ewsofsasnew,sproposedsstudysmaysbesusedsbysthesIRB?s-
sThesstudysinvolvessnosmoresthansminimalsrisksandsmeetssonesofsthesallowablescategoriessof
sexpeditedsreviewsspecifiedsinsfederalsregulations
AmendmentssinvolvingschangesstosIRBsapprovedsprotocolssdosNOTsneedspriorsIRBsapproval
sif:s-sTheschangessmustsbesimmediatelysimplementedsforstheshealthsandswell-
beingsofsthessubjects
IRBscontinuingsreviewsofsasgreatersthansminimalsrisksapprovedsprotocolsthatsisscurrentlysen
rollingssubjectssmust:s-soccursatsleastsannually
Informedsconsents-
sThesprocesssthatsbeginsswithsthesrecruitmentsandsscreeningsofsassubjectsandsthessigningsofst
hesconsentsdocumentsandscontinuessthroughoutsthessubject'ssinvolvementsinsthesresearchsa
ndsbeyondsstudystermination
InformedsconsentsissmandatedsbysthesUSsDepartmentsofsHHSsats45sCFRs46sandsthesUSsFDAsa
ts21sCFRs50.sThesesregulationssweresdevelopedsto:s-
s1)sprotectshumanssubjectss2)sEnsuresthatspotentialsstudyssubjectssclearlysunderstandsthesb
enefitssandsriskssassociatedswithstheirsparticipationsinsasstudys3)sProvidesthespotentialsstud
yssubjectsswithsallsinformationsneededstosreachsasdecisionsonswhethersorsnotstosparticipatesi
nsasresearchsstudy
Broadsconsents-sProspectivesconsentsforsunspecifiedsfuturesresearch
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