CIP CIP Vulnerable Populations & Special Protections

Question 1

Which subpart of 45 CFR 46 provides additional protections for pregnant women, human fetuses, and neonates?

Accepted Answer

Subpart B

Answer

Subpart A

Answer

Subpart C

Answer

Subpart D

Question 2

Under 45 CFR 46 Subpart D, research involving children may be approved if it presents greater than minimal risk with no direct benefit only when:

Accepted Answer

The risk represents only a minor increase over minimal risk and the intervention is commensurate with those in the child's actual situation

Answer

Any risk level is acceptable if parents consent

Answer

The IRB chair approves the risk level

Answer

The sponsor certifies the risk is justified

Question 3

What is required to enroll a child in research under 45 CFR 46 Subpart D when the research poses greater than minimal risk with direct benefit?

Accepted Answer

Permission of at least one parent or guardian and the child's assent

Answer

Permission of both parents and a court order

Answer

The child's assent alone is sufficient if they are over 12

Answer

Federal sponsor approval and both parents' permission

Question 4

Which federal subpart provides additional protections for prisoners as research subjects?

Accepted Answer

45 CFR 46 Subpart C

Answer

45 CFR 46 Subpart B

Answer

45 CFR 46 Subpart D

Answer

21 CFR 50 Subpart B

Question 5

When enrolling cognitively impaired adults in research, the IRB must ensure:

Accepted Answer

Consent or assent is obtained from the subject to the extent possible, along with LAR permission when required by the protocol risk level

Answer

The subject's diagnosis is the primary eligibility criterion

Answer

Consent from any family member is always sufficient

Answer

A court has formally declared the subject incompetent

Question 6

Under Subpart C, which of the following is a permissible category of research involving prisoners?

Accepted Answer

Research on conditions particularly affecting prisoners as a class, such as the effects of incarceration

Answer

Research designed solely to benefit the institution's security operations

Answer

Research that would not be conducted outside the prison setting for economic reasons

Answer

Any research approved by the warden and a majority of prisoners