x x x x x x
A xsubject xparticipates xin xa xdrug xstudy xbecause xtreatment xis xavailable xat xno xor xreduced xcost,
xand xhe xcould xnot xotherwise xafford xit. xThis xis xan xexample xof
A. Institutional xvulnerability
B. Communicative xvulnerability
C. Economic xvulnerability
D. Social xvulnerability x x x x x x x x xCorrect xans x x x- x xC. xEconomic xvulnerability
According xto xthe xauthors, xthere xare xfour xcommon xabuses xthat xhistorically xare xdescribed xas
xgiving xrise xto xvulnerability x. xWhich xresponse xbelow xcontains xthe xcorrect xfour?
A. Coercion, xundue xinfluence, xneglect xand xdisrespect
B. Physical xcontrol, xcoercion, xundue xinfluence, xand xmanipulation
C. Prejudice, xphysical xcontrol, xmanipulation xand xcoercion
D. Physical xcontrol, xcoercion, xundue xinfluence xand xneglect x x x x x x x x xCorrect xans x x x-B. xPhysical
xcontrol, xcoercion, xundue xinfluence, xand xmanipulation
Identify xthe xfollowing xgroups xthat xare xprotected xin xthe xfederal xregulations x(45 xCFR x46),
xspecifically xin xSubparts xB, xC, xand xD xwith xadditional xprotections:
A. Pregnant xwomen, xprisoners, xchildren
B. Prisoners, xchildren, xand xolder xadults
C. Pregnant xwomen, xprisoners, xand xindividuals xwho xare xeconomically xdisadvantaged
D. Children, xprisoners, xand xindividuals xwho xare xcritically xill x x x x x x x x xCorrect xans x x x-
A. xPregnant xwomen, xprisoners, xchildren
Subjects xwith xa xserious xillness xmay xbe xat xrisk xfor xexploitation xsince xthey xmay xbe xdesperate
xfor xa xpossible xcure. xThis xis xan xexample xof
A. Deferential xvulnerability
B. Therapeutic xmisconception
C. Medical xVulnerability
D. Economic xvulnerability x x x x x x x x xCorrect xans x x x- x xC. xMedical xVulnerability
Which xis xan xexample xof xa xsituation xwhere xdeferential xvulnerability xmight xbe xa xfactor?
A. A xcollege xprofessor xrecruiting xamong xhis xstudents
B. An xarmy xmedical xofficer xrecruiting xsubjects xamong xlower xranks
C. A xphysician xrecruiting xhis xpatients
D. An xemployer xrecruiting xamong xpersons xwho xdirectly xreport xto xhim x x x x x x x x xCorrect xans x x x-
x xC. xA xphysician xrecruiting xhis xpatients
,In xconsidering xNBAC's xanalytic xapproach, xan xotherwise xcompetent xperson xwho xis xacutely xill
xmight xbe xconsidered xat xespecially xhigh xrisk xof xharm xfor:
A. Economic xvulnerability
B. Communicative xvulnerability
C. Situational xcognitive xvulnerability
D. Capacity-related xcognitive xvulnerability x x x x x x x x xCorrect xans x x x- x xC. xSituational xcognitive
xvulnerability
When xan xIRB xis xreviewing xa xresearch xstudy xand xthey xare xconsidering xif xa xpotential xsubject
xpopulation xis xvulnerable, xthey xshould xconsider:
A. Are xthere xadequate xresources xto xconduct xthe xstudy?
B. Is xthere xa xpower xdifferential xbetween xresearchers xand xsubjects?
C. Are xthe xresearch xprocedures xgreater xthan xminimal xrisk xof xharm?
D. Has xthe xresearcher xcompleted xrequired xtraining? x x x x x x x x xCorrect xans x x x- x xB. xIs xthere xa
xpower xdifferential xbetween xresearchers xand xsubjects?
Which xis xtrue xof xinducements xin xresearch?
A. Like xcoercion, xundue xinducement xis xeasy xfor xIRBs xto xdetermine.
B. Offering x$10 xfor xan xhour xlong xresearch xstudy xconstitutes xundue xinducement.
C. Inducements, xlike xcoercion, xare xalways xinappropriate, xas xthey xviolate xthe xethical xprinciple
xof xrespect xfor xpersons.
D. Inducements xconstitute xan x"undue xinfluence" xif xthey xalter xa xpotential xsubject's xdecision-
making xprocesses, xsuch xthat xthey xdo xnot xappropriately xweigh xthe xrisk-benefit
xrelationship xof xthe xresearch. x x x x x x x x xCorrect xans x x x- x xD. xInducements xconstitute xan
x"undue xinfluence" xif xthey xalter xa xpotential xsubject's xdecision-making xprocesses, xsuch
xthat xthey xdo xnot xappropriately xweigh xthe xrisk-benefit xrelationship xof xthe xresearch.
NBAC xproposed xa xconcept xof xvulnerability xin xresearch xbased xon xfeatures xof xpotential
xsubjects xor xof xtheir xsituation. xWhich xof xthe xfollowing xwas xNOT xincluded xas xpossibly xleading
xto xvulnerability?
A. High xrisk xfor xexploitation
B. High xpotential xfor xindividual xbenefit xfrom xparticipating xin xresearch
C. Difficulty xproviding xvoluntary, xinformed xconsent xarising xfrom xlimitations xin xdecision-
making xcapacity
D. Difficulty xproviding xvoluntary, xinformed xconsent xarising xfrom xor xsituational xcircumstances
x x x x x x x x xCorrect xans x x x- x xB. xHigh xpotential xfor xindividual xbenefit xfrom xparticipating xin
xresearch
Which xof xthe xfollowing xbrought xincreased xpublic xattention xto xthe xproblems xwith xthe xIRB
xsystem?
, A. HHS xInspector xGeneral xReport xof x1998
B. 1983 xPresidential xCommission xReport
C. "Shut xDowns" xby xOHRP
D. Death xof xJesse xGelsinger x x x x x x x x xCorrect xans x x x- x xD. xDeath xof xJesse xGelsinger
Issued xin x1974, x45 xCFR x46 xraised xwhich xof xthe xfollowing xto xregulatory xstatus?
A. The x1974 xNational xResearch xAct
B. The xNuremberg xCode
C. Kefauver-Harris xDrug xAmendments xto xthe xFederal xFood, xDrug x& xCosmetics x
Act
D. US xPublic xHealth xService xPolicy x x x x x x x x xCorrect xans x x x- x xD. xUS xPublic xHealth xService xPolicy
The xNational xResearch xAct xof x1974
A. Identified xthe xbasic xethical xprinciples xof xhuman xsubjects xresearch
B. Identified xguidelines xto xensure xthe xethical xconduct xof xresearch.
C. Required xthat xall xfederal xagencies xhave xthe xsame xregulations xgoverning xhuman xsubjects
xresearch.
D. Established xthe xNational xCommission. x x x x x x x x xCorrect xans x x x- x xD. xEstablished xthe xNational
xCommission.
Informed xconsent xis xconsidered xan xapplication xof xwhich xBelmont xprinciple?
A. Non-maleficence
B. Beneficence
C. Respect xfor xPersons
D. Justice x x x x x x x x xCorrect xans x x x- x xC. xRespect xfor xPersons
Which xof xthe xfollowing xconcerns xis xrelated xto xthe xBelmont xPrinciple xof xJustice:
A. Prisoners xare xnot xfree xto xsay xno
B. Privacy xand xconfidentiality xconcerns xwhen xresearch xoccurs xin xprisons
C. Prisoners xparticipating xin xresearch xthat xonly xbenefits xthe xlarger xsociety
D. Prisoners xare xnot xa xrepresentative xsample xof xthe xgeneral xpopulation x x x x x x x x xCorrect xans x x
x- x xC. xPrisoners xparticipating xin xresearch xthat xonly xbenefits xthe xlarger xsociety
Which xof xthe xfollowing xwas xthe xresult xof xthe xBeecher xarticle?
A. An xidentification xof xbasic xethical xprinciples
B. Additional xFDA xregulations
C. Realization xthat xethical xabuses xare xnot xlimited xto xthe xNazi xregime