Institutional Review Board (IRB) Flashcards

For research involving children that poses greater than minimal risk and offers no direct benefit, which regulatory criterion must be met?

Answer: The risk must represent only a minor increase over minimal risk and yield generalizable knowledge about the disorder

Under 45 CFR 46.406, research with children involving more than minimal risk and no direct benefit must present only a minor increase over minimal risk and offer generalizable knowledge about the subjects' disorder or condition.

What is the key distinction between 'assent' and 'consent' in pediatric research?

Answer: Assent is the child's affirmative agreement; consent is the legally valid permission from parents or guardians

Assent refers to a child's affirmative agreement to participate, while parental or guardian consent provides the legally authorized permission.

Which federal subpart specifically provides additional protections for prisoners as research subjects?

Answer: 45 CFR 46 Subpart C

45 CFR 46 Subpart C specifically addresses additional protections for prisoners involved as research subjects.

Which of the following is a required safeguard when prisoners are enrolled in research?

Answer: At least one IRB member must be a prisoner or prisoner representative

45 CFR 46 Subpart C requires that a majority of the IRB members involved in reviewing prisoner research have no association with the prison, and at least one member must be a prisoner or prisoner representative.

When may an IRB waive the requirement to obtain parental permission for research involving children?

Answer: When the research involves no more than minimal risk and the waiver would not adversely affect subjects' rights

The IRB may waive parental permission when the research involves no more than minimal risk and the waiver would not adversely affect the rights and welfare of subjects.

What additional protection does 45 CFR 46 Subpart B require for research involving pregnant women?

Answer: Research must offer prospect of direct benefit to the woman, fetus, or both, or present only minimal risk

Subpart B allows research involving pregnant women when it offers the prospect of direct benefit or the risk to the fetus is no greater than minimal, among other conditions.

When a cognitively impaired adult lacks capacity to consent, what is the appropriate procedure?

Answer: A legally authorized representative (LAR) provides consent on the subject's behalf

When a prospective subject lacks decision-making capacity, a legally authorized representative (LAR) must provide consent in accordance with applicable law.