IRB Administration & Management Flashcards
7 cards from real CIP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 IRB Administration & Management flashcards as text
An IRB administrator receives a complaint from a research participant alleging coercion during recruitment. What is the FIRST administrative action?
Answer: Document the complaint and notify the IRB Chair immediately
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.
Which IRB administrative record retention period is required under federal HHS regulations at 45 CFR 46.115?
Answer: 3 years after study completion
45 CFR 46.115(b) requires that IRB records be retained for at least three years after completion of the research.
A full-board IRB convenes but quorum is lost mid-meeting when two members leave early. What must happen?
Answer: All pending votes must be tabled until quorum is restored or a new meeting is called
Federal regulations require that a quorum be present for any binding IRB vote; losing quorum mid-meeting requires stopping all further voting.
Which of the following best describes an IRB's responsibility regarding subpart B (pregnant women, fetuses, and neonates) of 45 CFR 46?
Answer: The IRB must apply additional risk/benefit standards specific to the pregnant woman and fetus
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.
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:
Answer: Return the amendment with a request for the missing consent forms before processing
Administrative staff should ensure submissions are complete before routing them for review, and should request any missing required documents from the PI.
Under 21 CFR 56.114, when an IRB reviews a multi-site FDA-regulated study, it may rely on another institution's IRB review through which mechanism?
Answer: A written authorization agreement transferring IRB review responsibilities
21 CFR 56.114 allows one IRB to rely on another's review through a formal written agreement that documents the transfer of oversight responsibilities.
A researcher proposes to use a deception protocol in which participants are not told the true purpose of the study. For a waiver of informed consent to be appropriate, the IRB must find that:
Answer: The research could not practicably be carried out without the deception and participants will be debriefed
A waiver or alteration of consent for deception research requires that the study cannot be conducted otherwise, and that participants receive a debriefing whenever appropriate.