SOCRA Vulnerable Populations and Pediatric Research (45 CFR 46 Subparts B–D, 21 CFR 50 Subpart D)

Question 1

Which subpart of 45 CFR 46 provides additional protections for children involved in research?

Accepted Answer

Subpart D

Answer

Subpart A is the Common Rule, Subpart B covers pregnant women, fetuses, and neonates, Subpart C covers prisoners, and Subpart D covers children.

Question 2

According to the regulations, which of these counts as a child's 'assent'?

Accepted Answer

The child affirmatively agrees to take part

Answer

Assent means a child's affirmative agreement to take part in research. Simply failing to object does not count as assent.

Question 3

Research involving children with greater than minimal risk and no prospect of direct benefit, but likely to produce vital knowledge about the child's condition (45 CFR 46.406), generally requires:

Accepted Answer

Permission from both parents, unless an exception applies

Answer

For 46.406 (21 CFR 50.53) research, both parents must give permission unless one is deceased, unknown, incompetent, not reasonably available, or only one parent has legal responsibility for the child.

Question 4

When an IRB reviews research involving prisoners under Subpart C, which membership requirement applies?

Accepted Answer

At least one member must be a prisoner or a prisoner representative

Answer

45 CFR 46.304 requires at least one IRB member to be a prisoner or a prisoner representative with appropriate background. A majority of members, excluding prisoner members, must have no association with the prison.

Question 5

Children who are wards of the state may be enrolled in 46.406 or 46.407 research only if the IRB requires:

Accepted Answer

An advocate appointed for each child

Answer

Under 45 CFR 46.409 and 21 CFR 50.56, an advocate must be appointed for each ward. The advocate acts in the child's best interest and is in addition to any guardian.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Vulnerable Populations and Pediatric Research (45 CFR 46 Subparts B–D, 21 CFR 50 Subpart D)