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

A healthy adult with a language barrier

Answer

A prisoner in a federal facility

Answer

An elderly subject with mild hypertension

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

Only when the child is over 18

Answer

Assent is never required if a parent consents

Answer

Only when the study involves more than minimal risk

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

21 CFR 50.27(c)

Answer

21 CFR 50.25(a)

Answer

45 CFR 46.111(a)

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

21 CFR 312

Answer

45 CFR 46 Subpart D

Answer

21 CFR 50.25

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

Proceed without further action since consent was obtained

Answer

Exclude the subject from the study

Answer

Obtain only LAR consent and discard the subject's consent

Question 6

Which element of informed consent must be disclosed when a study involves more than minimal risk?

Accepted Answer

Compensation available for research-related injury

Answer

The investigator's publication record

Answer

Names of all IRB members

Answer

The sponsor's financial projections

Question 7

A subject who does not speak English must be consented using a 'short form' consent document. What additional requirement applies?

Accepted Answer

A witness to the oral presentation must sign both the short form and the summary

Answer

The study must be halted until a full translation is available

Answer

Only the LAR needs to be present

Answer

The sponsor must approve the short form consent