CIP IRB Administration & Management 2

Question 1

An IRB administrator receives a complaint from a research participant alleging coercion during recruitment. What is the FIRST administrative action?

Accepted Answer

Document the complaint and notify the IRB Chair immediately

Answer

The first step is to document all details of the complaint and escalate to the IRB Chair, who can then determine if suspension or further investigation is warranted.

Question 2

Which IRB administrative record retention period is required under federal HHS regulations at 45 CFR 46.115?

Accepted Answer

3 years after study completion

Answer

45 CFR 46.115(b) requires that IRB records be retained for at least three years after completion of the research.

Question 3

A full-board IRB convenes but quorum is lost mid-meeting when two members leave early. What must happen?

Accepted Answer

All pending votes must be tabled until quorum is restored or a new meeting is called

Answer

Federal regulations require that a quorum be present for any binding IRB vote; losing quorum mid-meeting requires stopping all further voting.

Question 4

Which of the following best describes an IRB's responsibility regarding subpart B (pregnant women, fetuses, and neonates) of 45 CFR 46?

Accepted Answer

The IRB must apply additional risk/benefit standards specific to the pregnant woman and fetus

Answer

Subpart B imposes additional criteria the IRB must satisfy when approving research involving pregnant women, fetuses, or neonates, including separate risk/benefit analyses for each.

Question 5

An IRB administrator notices that a PI submitted an amendment to add a new research site but failed to include updated consent forms. The administrator should:

Accepted Answer

Return the amendment with a request for the missing consent forms before processing

Answer

Administrative staff should ensure submissions are complete before routing them for review, and should request any missing required documents from the PI.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP IRB Administration & Management 2