HSR Vulnerable Populations Protection 2 — Questions and Answers
Question 1: Which characteristic most commonly designates a population as 'vulnerable' in human subjects research?
- High educational attainment
- Susceptibility to undue influence or coercion (Correct answer)
- Willingness to participate without compensation
- Membership in a professional organization
Correct 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.
Question 2: Under 45 CFR 46 Subpart B, fetal research is permissible when:
- It poses no added risk to the fetus and holds prospect of direct benefit (Correct answer)
- Approved by the attending obstetrician without IRB review
- Conducted exclusively outside the United States
- Limited to pharmacological interventions only
Correct 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.
Question 3: In research involving cognitively impaired adults, which safeguard is most essential?
- Conducting all sessions online to reduce distress
- Obtaining surrogate consent from a legally authorized representative (Correct answer)
- Limiting each research session to under one hour
- Restricting the study to clinical hospital settings only
Correct 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.
Question 4: When recruiting employees as research participants, the most significant ethical concern is:
- Adequate sample size for statistical power
- Hierarchical coercion stemming from employer-employee relationships (Correct answer)
- Availability of suitable control groups
- Publication bias in reporting results
Correct 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.
Question 5: An IRB reviewing a study that compensates low-income participants with a large cash payment should be concerned about:
- The adequacy of the statistical analysis plan
- Whether the payment constitutes undue inducement to participate (Correct answer)
- The principal investigator's publication record
- Compliance with HIPAA administrative simplification rules
Correct 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.
Question 6: For children who are too young or developmentally unable to provide meaningful assent, which approach is correct?
- The research must be discontinued immediately
- Parental permission alone is sufficient if the IRB determines assent is not meaningful (Correct answer)
- An older sibling may provide assent on behalf of the child
- The child's primary care physician provides assent
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.
Question 7: Under 45 CFR 46 Subpart C, which condition must be met for prisoner research to receive IRB approval?
- Risks must be minimal or relate directly to their status as prisoners (Correct answer)
- All prisoner participants must be volunteers receiving no incentives whatsoever
- Research must take place exclusively outside prison facilities
- Study findings must primarily benefit non-prisoner populations
Correct 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.
HSR Vulnerable Populations Protection 2
Which characteristic most commonly designates a population as 'vulnerable' in human subjects research?