Vulnerable Populations Protection Flashcards

Which characteristic most commonly designates a population as 'vulnerable' in human subjects research?

Answer: Susceptibility to undue influence or coercion

Vulnerability in research ethics centers on the reduced ability to protect oneself from exploitation, coercion, or undue influence.

Under 45 CFR 46 Subpart B, fetal research is permissible when:

Answer: It poses no added risk to the fetus and holds prospect of direct benefit

Subpart B allows fetal research only when risk to the fetus is minimized and the research offers the prospect of direct benefit or is scientifically important with minimal risk.

In research involving cognitively impaired adults, which safeguard is most essential?

Answer: Obtaining surrogate consent from a legally authorized representative

When an adult lacks decision-making capacity, a legally authorized representative must provide surrogate consent to protect the individual's interests.

When recruiting employees as research participants, the most significant ethical concern is:

Answer: Hierarchical coercion stemming from employer-employee relationships

Employees may feel implicitly pressured to participate by supervisors or fear negative employment consequences for declining, constituting undue influence.

An IRB reviewing a study that compensates low-income participants with a large cash payment should be concerned about:

Answer: Whether the payment constitutes undue inducement to participate

Excessive compensation can undermine voluntariness by inducing economically disadvantaged individuals to accept risks they would otherwise decline.

For children who are too young or developmentally unable to provide meaningful assent, which approach is correct?

Answer: Parental permission alone is sufficient if the IRB determines assent is not meaningful

When the IRB determines a child cannot meaningfully assent due to age or developmental status, parental permission is the controlling consent mechanism.

Under 45 CFR 46 Subpart C, which condition must be met for prisoner research to receive IRB approval?

Answer: Risks must be minimal or relate directly to their status as prisoners

Subpart C requires that risks be commensurate with risks accepted by non-prisoner volunteers, or that research addresses conditions particularly affecting the prisoner population.