Ethical Principles in Research Flashcards

Under Subpart B of 45 CFR 46, research involving pregnant women must satisfy which condition to be permitted?

Answer: The risk to the fetus must be minimized and the research holds prospect of benefit to mother, fetus, or both

Subpart B requires that fetal risk be minimized and that the research offer the prospect of direct benefit to the pregnant woman and/or fetus, or contribute important knowledge.

When research involves prisoners as subjects, Subpart C of 45 CFR 46 requires that the proportion of prisoner subjects must be:

Answer: No more than minimal unless the research has direct benefit to prisoners as a class

Subpart C generally restricts research with prisoners to categories that offer direct benefit or study conditions particularly affecting prisoners, to prevent exploitation.

For research involving children, parental permission and child assent are required. Under what circumstance may the IRB waive the requirement for child assent?

Answer: When the research offers the prospect of direct benefit important to the child's health or well-being

The IRB may waive assent when the capability of some or all children is limited, or when the research offers direct benefit not obtainable outside the research context.

Which of the following is considered a 'vulnerable population' requiring additional protections in research?

Answer: Economically disadvantaged individuals who may be unduly influenced by payment

Economically disadvantaged individuals may be vulnerable to undue influence from financial incentives, requiring additional safeguards in research participation.

A participant with a cognitive impairment is enrolled in a study. Their legally authorized representative (LAR) has provided consent. The participant can express their wishes but cannot fully understand the study. The ethical approach is to:

Answer: Obtain LAR consent and also seek the participant's assent whenever possible

Best ethical practice requires seeking assent from participants with diminished capacity in addition to consent from their LAR, respecting their remaining autonomy.

Regarding research with children defined under 45 CFR 46 Subpart D, which category of research is permitted without direct benefit to the child if it presents only a minor increase over minimal risk?

Answer: Category III — minor increase over minimal risk with generalizable knowledge about the disorder

Category III (§46.406) allows a minor increase over minimal risk without direct benefit if the research yields generalizable knowledge about the child's disorder or condition.

An investigator plans to enroll students from their own university class in a study. What ethical concern does this primarily raise?

Answer: Undue influence or coercion due to the power differential between instructor and student

Enrolling one's own students raises concerns about coercion because the student-teacher power differential may compromise voluntariness of consent.