Populations in Research Requiring Additional Considerations
and/or Protections Q&A
A subject participates in a drug study because Subjects with a serious illness may be at risk for
treatment is available at no or reduced cost, and exploitation since they may be desperate for a
he could not otherwise afford it. This is an possible cure. This is an example of -
example of - ANSWER -Economic ANSWER -Medical Vulnerability
vulnerability
Which is true of inducements in research? -
According to the authors, there are four common ANSWER -Inducements constitute an
abuses that historically are described as giving "undue influence" if they alter a potential subject's
rise to vulnerability . Which response below decision-making processes, such that they do not
contains the correct four? - ANSWER - appropriately weigh the risk-benefit relationship
Physical control, coercion, undue influence, and of the research.
manipulation
In considering NBAC's analytic approach, an
otherwise competent person who is acutely ill
might be considered at especially high risk of
harm for: - ANSWER -Situational cognitive
vulnerability
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? - ANSWER -High potential for
individual benefit from participating in research
Identify the following groups that are protected in
the federal regulations (45 CFR 46), specifically
in Subparts B, C and D with additional
protections: - ANSWER -Pregnant women,
prisoners, children
When an IRB is reviewing a research study and
they are considering if a potential subject
population is vulnerable, they should consider: -
ANSWER -Is there a power differential
between researchers and subjects?
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and/or Protections Q&A
A subject participates in a drug study because Subjects with a serious illness may be at risk for
treatment is available at no or reduced cost, and exploitation since they may be desperate for a
he could not otherwise afford it. This is an possible cure. This is an example of -
example of - ANSWER -Economic ANSWER -Medical Vulnerability
vulnerability
Which is true of inducements in research? -
According to the authors, there are four common ANSWER -Inducements constitute an
abuses that historically are described as giving "undue influence" if they alter a potential subject's
rise to vulnerability . Which response below decision-making processes, such that they do not
contains the correct four? - ANSWER - appropriately weigh the risk-benefit relationship
Physical control, coercion, undue influence, and of the research.
manipulation
In considering NBAC's analytic approach, an
otherwise competent person who is acutely ill
might be considered at especially high risk of
harm for: - ANSWER -Situational cognitive
vulnerability
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? - ANSWER -High potential for
individual benefit from participating in research
Identify the following groups that are protected in
the federal regulations (45 CFR 46), specifically
in Subparts B, C and D with additional
protections: - ANSWER -Pregnant women,
prisoners, children
When an IRB is reviewing a research study and
they are considering if a potential subject
population is vulnerable, they should consider: -
ANSWER -Is there a power differential
between researchers and subjects?
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