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Populations in Research Requiring Additional Considerations and/or Protections
This deck covers key concepts related to vulnerabilities and protections for populations in research, based on historical abuses, federal regulations, and ethical considerations.
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
Economic vulnerability
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Key Terms
Term
Definition
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
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?
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:
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?
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:
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:
Is there a power differential between researchers and subjects?
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| Term | Definition |
|---|---|
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 | 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? | 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: | 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? | 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: | 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: | 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 | Medical Vulnerability |
Which is true of inducements in research? | 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. |