CIP CIP Vulnerable Populations & Special Protections 2 — Questions and Answers
Question 1: What is the primary ethical concern when enrolling economically disadvantaged individuals as research subjects?
- Undue inducement, where financial compensation may compromise voluntariness (Correct answer)
- Lack of scientific relevance to their health conditions
- Inability to provide written consent
- Non-compliance with study procedures due to socioeconomic factors
Correct 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.
Question 2: An IRB reviewing research involving students enrolled in the investigator's own courses must scrutinize which concern most carefully?
- Undue influence and coercion arising from the power differential between instructor and student (Correct answer)
- Whether the research questions are sufficiently academic
- Whether FERPA applies to the data collected
- Whether the institution has an FWA covering educational research
Correct 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.
Question 3: For research involving neonates of uncertain viability, 45 CFR 46 Subpart B requires:
- 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 (Correct answer)
- The PI's judgment that the neonate is viable before enrollment
- Only the mother's consent and IRB approval
- Federal agency approval for each individual enrollment
Correct 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.
Question 4: Which of the following best characterizes the concept of 'assent' in pediatric research?
- A child's affirmative agreement to participate, which must be given appropriate weight even though it does not replace parental permission (Correct answer)
- A child's signature on the adult consent form
- Legal authorization provided by an adolescent aged 18 or older
- A formal document replacing parental permission for mature minors
Correct 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.
Question 5: OHRP guidance recommends that IRBs consider which factor when determining if a waiver of assent is appropriate for children?
- Whether the research offers direct benefit available only in the research context (Correct answer)
- Whether the IRB has pediatric expertise on its panel
- Whether the sponsor is a federal agency
- Whether the study is Phase I or Phase II
Correct 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.
Question 6: When a prisoner becomes eligible for parole during a study, the IRB's concern is:
- That the prospect of parole may have unduly influenced consent and the subject should be reconsented to confirm continued voluntary participation (Correct answer)
- That prison officials must approve continued enrollment
- That the subject's data must be destroyed immediately
- That a new LAR must be designated
Correct 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.
CIP CIP Vulnerable Populations & Special Protections 2
What is the primary ethical concern when enrolling economically disadvantaged individuals as research subjects?