CIP Vulnerable Populations & Special Protections Flashcards
6 cards from real CIP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CIP Vulnerable Populations & Special Protections flashcards as text
What is the primary ethical concern when enrolling economically disadvantaged individuals as research subjects?
Answer: Undue inducement, where financial compensation may compromise voluntariness
Economically disadvantaged populations may be unduly influenced by payment offers that would not similarly compromise wealthier individuals, threatening voluntary participation.
An IRB reviewing research involving students enrolled in the investigator's own courses must scrutinize which concern most carefully?
Answer: Undue influence and coercion arising from the power differential between instructor and student
The instructor-student power dynamic creates a coercive environment in which students may feel unable to freely decline participation.
For research involving neonates of uncertain viability, 45 CFR 46 Subpart B requires:
Answer: Consent of both parents and that the research holds out the prospect of enhancing the neonate's probability of survival or cannot be obtained by other means
Subpart B 46.205 imposes strict conditions for neonates of uncertain viability, requiring dual parental consent and a direct benefit or no-alternative standard.
Which of the following best characterizes the concept of 'assent' in pediatric research?
Answer: A child's affirmative agreement to participate, which must be given appropriate weight even though it does not replace parental permission
Assent reflects the child's own voice in the research process and must be genuinely sought, though parental permission remains legally required in most cases.
OHRP guidance recommends that IRBs consider which factor when determining if a waiver of assent is appropriate for children?
Answer: Whether the research offers direct benefit available only in the research context
Assent may be waived when the research offers direct benefit that is only available through the research protocol and would not otherwise be available to the child.
When a prisoner becomes eligible for parole during a study, the IRB's concern is:
Answer: That the prospect of parole may have unduly influenced consent and the subject should be reconsented to confirm continued voluntary participation
Impending parole can retroactively raise questions about whether initial consent was truly voluntary, warranting re-evaluation of the subject's willingness to continue.