1. C. Economic vul- A subject participates in a drug study because treatment is
nerability 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
2. B. Physical con- According to the authors, there are four common abuses
trol, coercion, un- that historically are described as giving rise to vulnerability
due influence, . Which response below contains the correct four?
and manipulation
A. Coercion, undue influence, neglect and disrespect
B. Physical control, coercion, undue influence, and manip-
ulation
C. Prejudice, physical control, manipulation and coercion
D. Physical control, coercion, undue influence and neglect
3. A. Pregnant Identify the following groups that are protected in the fed-
women, prison- eral regulations (45 CFR 46), specifically in Subparts B,
ers, children 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
4. C. Medical Vul- Subjects with a serious illness may be at risk for exploita-
nerability tion 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
5.
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C. A physician re- Which is an example of a situation where deferential vul-
cruiting his pa- nerability might be a factor?
tients
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
6. C. Situational In considering NBAC's analytic approach, an otherwise
cognitive vulner- competent person who is acutely ill might be considered
ability at especially high risk of harm for:
A. Economic vulnerability
B. Communicative vulnerability
C. Situational cognitive vulnerability
D. Capacity-related cognitive vulnerability
7. B. Is there a When an IRB is reviewing a research study and they are
power differen- considering if a potential subject population is vulnerable,
tial between re- they should consider:
searchers and
subjects? 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?
8. D. Inducements Which is true of inducements in research?
constitute an
"undue A. Like coercion, undue inducement is easy for IRBs to
influence" if they determine.
alter a potential B. Offering $10 for an hour long research study constitutes
subject's undue inducement.
decision-making C. Inducements, like coercion, are always inappropriate,
processes, such as they violate the ethical principle of respect for persons.
that they do not D. Inducements constitute an "undue influence" if they al-
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appropriately ter a potential subject's decision-making processes, such
weigh the that they do not appropriately weigh the risk-benefit rela-
risk-benefit tionship of the research.
relationship of
the research.
9. B. High poten- NBAC proposed a concept of vulnerability in research
tial for individual based on features of potential subjects or of their situation.
benefit from par- Which of the following was NOT included as possibly
ticipating in re- leading to vulnerability?
search
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
10. D. Death of Jesse Which of the following brought increased public attention
Gelsinger to the problems with the IRB system?
A. HHS Inspector General Report of 1998
B. 1983 Presidential Commission Report
C. "Shut Downs" by OHRP
D. Death of Jesse Gelsinger
11. D. US Public Issued in 1974, 45 CFR 46 raised which of the following
Health Service to regulatory status?
Policy
A. The 1974 National Research Act
B. The Nuremberg Code
C. Kefauver-Harris Drug Amendments to the Federal
Food, Drug & Cosmetics Act
D. US Public Health Service Policy
12. D. Established The National Research Act of 1974
the National
Commission. A. Identified the basic ethical principles of human subjects
research