Populations in Research Requiring Additional Considerations and/or Protections
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 Correct Answer: 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? Correct Answer: Physical
control, coercion, undue influence, and 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: Correct 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?
Correct 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: Correct 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: Correct Answer: Is there a power differential
between researchers and subjects?
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 Correct Answer: Medical Vulnerability
Which is true of inducements in research? Correct Answer: 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.
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 Correct Answer: 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? Correct Answer: Physical
control, coercion, undue influence, and 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: Correct 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?
Correct 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: Correct 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: Correct Answer: Is there a power differential
between researchers and subjects?
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 Correct Answer: Medical Vulnerability
Which is true of inducements in research? Correct Answer: 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.
