CITI Program
PMOC · ITIC
C Research Ethics & Compliance Training
★ ★
EST. 2000
A D V A N C I N G K N O W L E D G E T O I M P R O V E H U M A N H E A LT H
CITI Training Comprehensive Examination
VU L N E RA B I L I TY, I R B , B E L M O N T R E P O RT, I N FO R M E D CO N S E N T, P R I VACY, CO I , H I PA A
& MORE
INSTITUTION CITI Program PROGRAM Human Subjects Research (HSR)
Training
COURSE CITI Modules 1–17 Comprehensive ACADEMIC YEAR
Review
EXAM TYPE Comprehensive Examination — TOTAL QUESTIONS 150+ Questions
Verified Answers
CONTENT AREAS Vulnerability, IRB, Belmont, FORMAT Multiple Choice — Select the
Consent, COI, HIPAA, Genetics Single Best Answer
EXAMINATION INSTRUCTIONS
▸ Select the single best answer for each question.
▸ Topics: Vulnerability types, IRB review, Belmont Report, informed consent, COI, HIPAA, genetic research,
FDA regulations, prisoners/children/pregnant women protections.
▸ All content derived from CITI Program training modules.
▸ Correct answers and detailed rationales appear below each question.
SECTION I — CITI COMPREHENSIVE EXAMINATION All Questions
,1. 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 which type of
vulnerability?
A. Institutional vulnerability
B. Communicative vulnerability
C. Economic vulnerability
D. Social vulnerability
CORRECT ANSWER C — Economic vulnerability
RATIONALE Economic vulnerability arises when financial circumstances compromise
voluntary decision-making. When treatment is only accessible through research
due to cost, subjects may feel they have no real choice.
2. According to the authors, there are four common abuses that historically give rise to
vulnerability. Which response 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 ANSWER B — Physical control, coercion, undue influence, and manipulation
RATIONALE The four historically recognized abuses are: physical control (restricting freedom),
coercion (explicit threats), undue influence (excessive incentives), and
manipulation (deception).
,3. Identify the groups protected in 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 economically disadvantaged
D. Children, prisoners, and critically ill individuals
CORRECT ANSWER A — Pregnant women, prisoners, children
RATIONALE Subpart B covers pregnant women/fetuses/neonates; Subpart C covers prisoners;
Subpart D covers children. Older adults and economically disadvantaged are not
in specific subparts.
4. 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 which type of vulnerability?
A. Deferential vulnerability
B. Therapeutic misconception
C. Medical Vulnerability
D. Economic vulnerability
CORRECT ANSWER C — Medical Vulnerability
RATIONALE Medical vulnerability occurs when a serious health condition creates desperation
for treatment, impairing the ability to objectively assess research risks and
benefits.
, 5. 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 ANSWER C — A physician recruiting his patients
RATIONALE Deferential vulnerability exists when subjects defer to the perceived authority of
the researcher — patients may feel obligated to participate because their doctor
asked them.
6. In considering NBAC's analytic approach, an otherwise competent person who is acutely
ill might be considered at especially high risk for which type of cognitive vulnerability?
A. Economic vulnerability
B. Communicative vulnerability
C. Situational cognitive vulnerability
D. Capacity-related cognitive vulnerability
CORRECT ANSWER C — Situational cognitive vulnerability
RATIONALE Acute illness creates SITUATIONAL cognitive vulnerability — the person is
normally competent but their current medical condition temporarily impairs
decision-making capacity. This differs from capacity-related vulnerability
(permanent impairment).
PMOC · ITIC
C Research Ethics & Compliance Training
★ ★
EST. 2000
A D V A N C I N G K N O W L E D G E T O I M P R O V E H U M A N H E A LT H
CITI Training Comprehensive Examination
VU L N E RA B I L I TY, I R B , B E L M O N T R E P O RT, I N FO R M E D CO N S E N T, P R I VACY, CO I , H I PA A
& MORE
INSTITUTION CITI Program PROGRAM Human Subjects Research (HSR)
Training
COURSE CITI Modules 1–17 Comprehensive ACADEMIC YEAR
Review
EXAM TYPE Comprehensive Examination — TOTAL QUESTIONS 150+ Questions
Verified Answers
CONTENT AREAS Vulnerability, IRB, Belmont, FORMAT Multiple Choice — Select the
Consent, COI, HIPAA, Genetics Single Best Answer
EXAMINATION INSTRUCTIONS
▸ Select the single best answer for each question.
▸ Topics: Vulnerability types, IRB review, Belmont Report, informed consent, COI, HIPAA, genetic research,
FDA regulations, prisoners/children/pregnant women protections.
▸ All content derived from CITI Program training modules.
▸ Correct answers and detailed rationales appear below each question.
SECTION I — CITI COMPREHENSIVE EXAMINATION All Questions
,1. 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 which type of
vulnerability?
A. Institutional vulnerability
B. Communicative vulnerability
C. Economic vulnerability
D. Social vulnerability
CORRECT ANSWER C — Economic vulnerability
RATIONALE Economic vulnerability arises when financial circumstances compromise
voluntary decision-making. When treatment is only accessible through research
due to cost, subjects may feel they have no real choice.
2. According to the authors, there are four common abuses that historically give rise to
vulnerability. Which response 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 ANSWER B — Physical control, coercion, undue influence, and manipulation
RATIONALE The four historically recognized abuses are: physical control (restricting freedom),
coercion (explicit threats), undue influence (excessive incentives), and
manipulation (deception).
,3. Identify the groups protected in 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 economically disadvantaged
D. Children, prisoners, and critically ill individuals
CORRECT ANSWER A — Pregnant women, prisoners, children
RATIONALE Subpart B covers pregnant women/fetuses/neonates; Subpart C covers prisoners;
Subpart D covers children. Older adults and economically disadvantaged are not
in specific subparts.
4. 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 which type of vulnerability?
A. Deferential vulnerability
B. Therapeutic misconception
C. Medical Vulnerability
D. Economic vulnerability
CORRECT ANSWER C — Medical Vulnerability
RATIONALE Medical vulnerability occurs when a serious health condition creates desperation
for treatment, impairing the ability to objectively assess research risks and
benefits.
, 5. 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 ANSWER C — A physician recruiting his patients
RATIONALE Deferential vulnerability exists when subjects defer to the perceived authority of
the researcher — patients may feel obligated to participate because their doctor
asked them.
6. In considering NBAC's analytic approach, an otherwise competent person who is acutely
ill might be considered at especially high risk for which type of cognitive vulnerability?
A. Economic vulnerability
B. Communicative vulnerability
C. Situational cognitive vulnerability
D. Capacity-related cognitive vulnerability
CORRECT ANSWER C — Situational cognitive vulnerability
RATIONALE Acute illness creates SITUATIONAL cognitive vulnerability — the person is
normally competent but their current medical condition temporarily impairs
decision-making capacity. This differs from capacity-related vulnerability
(permanent impairment).
