CPI Research Ethics & Compliance 2

Question 1

A researcher discovers mid-study that a participant is experiencing an unanticipated serious adverse event. What is the FIRST required action?

Accepted Answer

Report immediately to the IRB and sponsor per protocol

Answer

Unanticipated problems involving risks to participants must be reported promptly to the IRB and sponsor as required by federal regulations.

Question 2

Under 45 CFR 46, which of the following research populations requires additional protections beyond the Basic Policy?

Accepted Answer

Prisoners as research subjects

Answer

Subpart C of 45 CFR 46 provides additional federal protections specifically for prisoners involved in research.

Question 3

What does the principle of 'justice' in the Belmont Report primarily require researchers to do?

Accepted Answer

Distribute research burdens and benefits fairly across society

Answer

Justice requires equitable selection of subjects so that vulnerable populations are not exploited and benefits are distributed fairly.

Question 4

A PI wants to conduct a telephone survey on dietary habits with no sensitive questions. Which IRB review category most likely applies?

Accepted Answer

Exempt review

Answer

Survey research involving no sensitive topics and no identifiable data typically qualifies for exempt status under 45 CFR 46.104(d).

Question 5

What is the primary purpose of a Data Safety Monitoring Board (DSMB) in a clinical trial?

Accepted Answer

To independently monitor accumulating data and safeguard participant safety

Answer

A DSMB independently reviews interim data to protect participant safety and ensure the trial's continued validity.

(CPI) Certified Principal Investigator Practice Test