SOCRA The Informed Consent Process 2

Question 1

Which of the following subjects requires consent from a Legally Authorized Representative (LAR) rather than the subject themselves?

Accepted Answer

A minor child enrolled in a pediatric trial

Answer

Minor children lack legal capacity to provide independent informed consent, so an LAR (parent or guardian) must consent on their behalf.

Question 2

Under 21 CFR 50.55, when must a child's assent be obtained in addition to parental permission?

Accepted Answer

When the IRB determines the child is capable of providing assent

Answer

The IRB determines on a case-by-case basis whether children are capable of providing assent, and if so, assent must be obtained.

Question 3

An investigator wants to waive the requirement for signed informed consent documentation. Which regulation governs this waiver?

Accepted Answer

45 CFR 46.117(c)

Answer

45 CFR 46.117(c) permits the IRB to waive the requirement for a signed consent form under specific conditions.

Question 4

When enrolling prisoners in research, which additional federal regulation applies beyond standard informed consent requirements?

Accepted Answer

45 CFR 46 Subpart C

Answer

45 CFR 46 Subpart C specifically addresses additional protections for prisoners as a vulnerable population in research.

Question 5

A subject with fluctuating decision-making capacity signs consent during a lucid interval. What is the most appropriate next step?

Accepted Answer

Obtain concurrent LAR consent and reassess capacity regularly

Answer

Best practice for subjects with fluctuating capacity is to obtain both LAR consent and subject assent, with ongoing capacity reassessment.

(SOCRA) Society of Clinical Research Associates Practice Test