Vulnerable Populations Protection Flashcards

Under 45 CFR 46, which Subpart provides additional protections specifically for children involved in research?

Answer: Subpart D

Subpart D of 45 CFR 46 contains additional protections for children as research subjects, requiring parental permission and child assent.

When a child is capable of understanding a research study, the researcher must obtain:

Answer: Assent from the child and parental permission

Federal regulations require both parental permission and the child's affirmative assent when the child is capable of providing it.

Which ethical principle from the Belmont Report is most directly invoked when ensuring vulnerable populations are not exploited in research?

Answer: Justice

Justice requires that the benefits and burdens of research be distributed fairly and that vulnerable groups are not disproportionately enrolled to serve others' interests.

Pregnant women are classified as a vulnerable population in human subjects research primarily because:

Answer: Research risks may extend to the developing fetus

Pregnant women require additional protections because interventions or exposures can affect not only the woman but also the fetus.

A legally authorized representative (LAR) is most commonly required in research when a participant:

Answer: Lacks decision-making capacity

An LAR is needed when an adult lacks the cognitive or legal capacity to provide meaningful informed consent on their own behalf.

Under 45 CFR 46 Subpart C, which category of research involving prisoners is explicitly permissible?

Answer: Research on conditions particularly affecting prisoners as a class

Subpart C permits research on conditions such as vaccine trials for hepatitis because hepatitis disproportionately affects prisoners as a class.

When may an IRB waive the requirement for parental permission for a minor's participation in research?

Answer: When parental permission is not a reasonable requirement to protect the subjects

An IRB may waive parental permission when requiring it would not reasonably protect the child, such as in research on abused or neglected children.