CITI Training/Questions And Answers/100% Correct/
Best Scores.
A subject participates in a drug study because treatment is available at no or
reduced cost, and he could not otherwise afford it. This is an example of
A. Institutional vulnerability
B. Communicative vulnerability
C. Economic vulnerability
D. Social vulnerability Correct ans - C. Economic vulnerability
According to the authors, there are four common abuses that historically are
described as giving rise to vulnerability . Which response below contains the
correct four?
A. Coercion, undue influence, neglect and disrespect
B. Physical control, coercion, undue influence, and manipulation
C. Prejudice, physical control, manipulation and coercion
D. Physical control, coercion, undue influence and neglect Correct ans -
B. Physical control, coercion, undue influence, and manipulation
Identify the following groups that are protected in the federal regulations (45
CFR 46), specifically in Subparts B, C, and D with additional protections:
A. Pregnant women, prisoners, children
B. Prisoners, children, and older adults
C. Pregnant women, prisoners, and individuals who are economically
disadvantaged
D. Children, prisoners, and individuals who are critically ill Correct ans -
A. Pregnant women, prisoners, children
Subjects with a serious illness may be at risk for exploitation since they may
be desperate for a possible cure. This is an example of
A. Deferential vulnerability
B. Therapeutic misconception
C. Medical Vulnerability
D. Economic vulnerability Correct ans - C. Medical Vulnerability
Which is an example of a situation where deferential vulnerability might be a
factor?
A. A college professor recruiting among his students
B. An army medical officer recruiting subjects among lower ranks
C. A physician recruiting his patients
,D. An employer recruiting among persons who directly report to him
Correct ans - C. A physician recruiting his patients
In considering NBAC's analytic approach, an otherwise competent person
who is acutely ill might be considered at especially high risk of harm for:
A. Economic vulnerability
B. Communicative vulnerability
C. Situational cognitive vulnerability
D. Capacity-related cognitive vulnerability Correct ans - C. Situational
cognitive vulnerability
When an IRB is reviewing a research study and they are considering if a
potential subject population is vulnerable, they should consider:
A. Are there adequate resources to conduct the study?
B. Is there a power differential between researchers and subjects?
C. Are the research procedures greater than minimal risk of harm?
D. Has the researcher completed required training? Correct ans - B. Is
there a power differential between researchers and subjects?
Which is true of inducements in research?
A. Like coercion, undue inducement is easy for IRBs to determine.
B. Offering $10 for an hour long research study constitutes undue
inducement.
C. Inducements, like coercion, are always inappropriate, as they violate the
ethical principle of respect for persons.
D. Inducements constitute an "undue influence" if they alter a potential
subject's decision-making processes, such that they do not appropriately
weigh the risk-benefit relationship of the research. Correct ans - D.
Inducements constitute an "undue influence" if they alter a potential
subject's decision-making processes, such that they do not appropriately
weigh the risk-benefit relationship of the research.
NBAC proposed a concept of vulnerability in research based on features of
potential subjects or of their situation. Which of the following was NOT
included as possibly leading to vulnerability?
A. High risk for exploitation
B. High potential for individual benefit from participating in research
C. Difficulty providing voluntary, informed consent arising from limitations in
decision-making capacity
D. Difficulty providing voluntary, informed consent arising from or situational
circumstances Correct ans - B. High potential for individual benefit
from participating in research
, Which lof lthe lfollowing lbrought lincreased lpublic lattention lto lthe lproblems
lwith lthe lIRB lsystem?
A. lHHS lInspector lGeneral lReport lof l1998
B. l 1983 l Presidential l Commission l Report
C. l"Shut lDowns" lby lOHRP
D. lDeath lof lJesse lGelsinger Correct lans - l D. lDeath lof lJesse lGelsinger
Issued lin l 1974, l45 l CFR l 46 lraised l which l of l the lfollowing l to lregulatory l status?
A. l The l1974 l National l Research l Act
B. lThe l Nuremberg l Code
C. lKefauver-Harris lDrug lAmendments lto lthe lFederal lFood, lDrug l& lCosmetics lAct
D. lUS lPublic lHealth lService lPolicy Correct lans - l D. lUS lPublic lHealth
lService lPolicy
The lNational lResearch lAct lof l1974
A. lIdentified lthe lbasic lethical lprinciples lof lhuman lsubjects lresearch
B. lIdentified lguidelines lto lensure lthe lethical lconduct lof lresearch.
C. lRequired lthat lall lfederal lagencies lhave lthe lsame lregulations lgoverning
lhuman lsubjects lresearch.
D. lEstablished lthe lNational lCommission. Correct lans - l D. lEstablished
lthe lNational lCommission.
Informed lconsent lis l considered lan lapplication lof lwhich lBelmont lprinciple?
A. lNon-maleficence
B. lBeneficence
C. lRespect lfor lPersons
D. lJustice Correct lans - l C. lRespect lfor lPersons
Which lof lthe lfollowing lconcerns lis lrelated lto lthe lBelmont lPrinciple lof lJustice:
A. lPrisoners lare lnot lfree lto lsay lno
B. lPrivacy land lconfidentiality lconcerns lwhen lresearch loccurs lin lprisons
C. lPrisoners lparticipating lin lresearch lthat lonly lbenefits lthe llarger lsociety
D. lPrisoners lare lnot la lrepresentative lsample lof lthe lgeneral lpopulation
lCorrect lans - l C. lPrisoners lparticipating lin lresearch lthat lonly lbenefits lthe
llarger lsociety
Which lof lthe lfollowing lwas lthe lresult lof lthe lBeecher larticle?
A. l An l identification l of l basic l ethical l principles
Best Scores.
A subject participates in a drug study because treatment is available at no or
reduced cost, and he could not otherwise afford it. This is an example of
A. Institutional vulnerability
B. Communicative vulnerability
C. Economic vulnerability
D. Social vulnerability Correct ans - C. Economic vulnerability
According to the authors, there are four common abuses that historically are
described as giving rise to vulnerability . Which response below contains the
correct four?
A. Coercion, undue influence, neglect and disrespect
B. Physical control, coercion, undue influence, and manipulation
C. Prejudice, physical control, manipulation and coercion
D. Physical control, coercion, undue influence and neglect Correct ans -
B. Physical control, coercion, undue influence, and manipulation
Identify the following groups that are protected in the federal regulations (45
CFR 46), specifically in Subparts B, C, and D with additional protections:
A. Pregnant women, prisoners, children
B. Prisoners, children, and older adults
C. Pregnant women, prisoners, and individuals who are economically
disadvantaged
D. Children, prisoners, and individuals who are critically ill Correct ans -
A. Pregnant women, prisoners, children
Subjects with a serious illness may be at risk for exploitation since they may
be desperate for a possible cure. This is an example of
A. Deferential vulnerability
B. Therapeutic misconception
C. Medical Vulnerability
D. Economic vulnerability Correct ans - C. Medical Vulnerability
Which is an example of a situation where deferential vulnerability might be a
factor?
A. A college professor recruiting among his students
B. An army medical officer recruiting subjects among lower ranks
C. A physician recruiting his patients
,D. An employer recruiting among persons who directly report to him
Correct ans - C. A physician recruiting his patients
In considering NBAC's analytic approach, an otherwise competent person
who is acutely ill might be considered at especially high risk of harm for:
A. Economic vulnerability
B. Communicative vulnerability
C. Situational cognitive vulnerability
D. Capacity-related cognitive vulnerability Correct ans - C. Situational
cognitive vulnerability
When an IRB is reviewing a research study and they are considering if a
potential subject population is vulnerable, they should consider:
A. Are there adequate resources to conduct the study?
B. Is there a power differential between researchers and subjects?
C. Are the research procedures greater than minimal risk of harm?
D. Has the researcher completed required training? Correct ans - B. Is
there a power differential between researchers and subjects?
Which is true of inducements in research?
A. Like coercion, undue inducement is easy for IRBs to determine.
B. Offering $10 for an hour long research study constitutes undue
inducement.
C. Inducements, like coercion, are always inappropriate, as they violate the
ethical principle of respect for persons.
D. Inducements constitute an "undue influence" if they alter a potential
subject's decision-making processes, such that they do not appropriately
weigh the risk-benefit relationship of the research. Correct ans - D.
Inducements constitute an "undue influence" if they alter a potential
subject's decision-making processes, such that they do not appropriately
weigh the risk-benefit relationship of the research.
NBAC proposed a concept of vulnerability in research based on features of
potential subjects or of their situation. Which of the following was NOT
included as possibly leading to vulnerability?
A. High risk for exploitation
B. High potential for individual benefit from participating in research
C. Difficulty providing voluntary, informed consent arising from limitations in
decision-making capacity
D. Difficulty providing voluntary, informed consent arising from or situational
circumstances Correct ans - B. High potential for individual benefit
from participating in research
, Which lof lthe lfollowing lbrought lincreased lpublic lattention lto lthe lproblems
lwith lthe lIRB lsystem?
A. lHHS lInspector lGeneral lReport lof l1998
B. l 1983 l Presidential l Commission l Report
C. l"Shut lDowns" lby lOHRP
D. lDeath lof lJesse lGelsinger Correct lans - l D. lDeath lof lJesse lGelsinger
Issued lin l 1974, l45 l CFR l 46 lraised l which l of l the lfollowing l to lregulatory l status?
A. l The l1974 l National l Research l Act
B. lThe l Nuremberg l Code
C. lKefauver-Harris lDrug lAmendments lto lthe lFederal lFood, lDrug l& lCosmetics lAct
D. lUS lPublic lHealth lService lPolicy Correct lans - l D. lUS lPublic lHealth
lService lPolicy
The lNational lResearch lAct lof l1974
A. lIdentified lthe lbasic lethical lprinciples lof lhuman lsubjects lresearch
B. lIdentified lguidelines lto lensure lthe lethical lconduct lof lresearch.
C. lRequired lthat lall lfederal lagencies lhave lthe lsame lregulations lgoverning
lhuman lsubjects lresearch.
D. lEstablished lthe lNational lCommission. Correct lans - l D. lEstablished
lthe lNational lCommission.
Informed lconsent lis l considered lan lapplication lof lwhich lBelmont lprinciple?
A. lNon-maleficence
B. lBeneficence
C. lRespect lfor lPersons
D. lJustice Correct lans - l C. lRespect lfor lPersons
Which lof lthe lfollowing lconcerns lis lrelated lto lthe lBelmont lPrinciple lof lJustice:
A. lPrisoners lare lnot lfree lto lsay lno
B. lPrivacy land lconfidentiality lconcerns lwhen lresearch loccurs lin lprisons
C. lPrisoners lparticipating lin lresearch lthat lonly lbenefits lthe llarger lsociety
D. lPrisoners lare lnot la lrepresentative lsample lof lthe lgeneral lpopulation
lCorrect lans - l C. lPrisoners lparticipating lin lresearch lthat lonly lbenefits lthe
llarger lsociety
Which lof lthe lfollowing lwas lthe lresult lof lthe lBeecher larticle?
A. l An l identification l of l basic l ethical l principles
