CIP CIP Vulnerable Populations & Special Protections 2

Question 1

What is the primary ethical concern when enrolling economically disadvantaged individuals as research subjects?

Accepted Answer

Undue inducement, where financial compensation may compromise voluntariness

Answer

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?

Accepted Answer

Undue influence and coercion arising from the power differential between instructor and student

Answer

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:

Accepted 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

Answer

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?

Accepted Answer

A child's affirmative agreement to participate, which must be given appropriate weight even though it does not replace parental permission

Answer

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?

Accepted Answer

Whether the research offers direct benefit available only in the research context

Answer

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.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP CIP Vulnerable Populations & Special Protections 2