ACRP – CP Exam (Latest 2024 – 2025) With Complete Solution

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