Populations in Research Requiring Additional Considerations and/or Protections

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

The NBAC looks at characteristics individual might have that would prevent them from being able o provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional,deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a:

Cognitive or communicative 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

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

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.

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

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