CIP IRB Administration & Management 2 — Questions and Answers
Question 1: An IRB administrator receives a complaint from a research participant alleging coercion during recruitment. What is the FIRST administrative action?
- Dismiss the complaint if the PI denies it
- Document the complaint and notify the IRB Chair immediately (Correct answer)
- Contact the sponsor to inform them of the allegation
- Suspend the study pending a formal investigation
Correct 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.
Question 2: Which IRB administrative record retention period is required under federal HHS regulations at 45 CFR 46.115?
- 1 year after study completion
- 3 years after study completion (Correct answer)
- 5 years after study completion
- 10 years after study completion
Correct 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.
Question 3: A full-board IRB convenes but quorum is lost mid-meeting when two members leave early. What must happen?
- The remaining members may continue voting on non-sensitive studies
- All pending votes must be tabled until quorum is restored or a new meeting is called (Correct answer)
- The chair may cast double votes to compensate for absent members
- Decisions already made before quorum was lost are automatically invalidated
Correct 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.
Question 4: Which of the following best describes an IRB's responsibility regarding subpart B (pregnant women, fetuses, and neonates) of 45 CFR 46?
- Subpart B applies only to FDA-regulated research
- The IRB must apply additional risk/benefit standards specific to the pregnant woman and fetus (Correct answer)
- Subpart B prohibits all research involving pregnant participants
- Only the DSMB, not the IRB, reviews subpart B compliance
Correct 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.
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:
- Approve the amendment provisionally and remind the PI later
- Return the amendment with a request for the missing consent forms before processing (Correct answer)
- Forward the incomplete amendment to full-board review as submitted
- Contact the new site directly to draft consent forms on behalf of the PI
Correct 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.
Question 6: 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?
- A verbal agreement between IRB chairs
- A written authorization agreement transferring IRB review responsibilities (Correct answer)
- An automatic reciprocity clause in the Common Rule
- A waiver of review granted by the FDA
Correct 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.
Question 7: 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:
- The deception is scientifically novel and the PI has prior publications
- Debriefing is impossible due to the sensitive nature of the topic
- The research could not practicably be carried out without the deception and participants will be debriefed (Correct answer)
- The sponsor has approved the deception and agreed to indemnify participants
Correct 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.
CIP IRB Administration & Management 2
An IRB administrator receives a complaint from a research participant alleging coercion during recruitment.
What is the FIRST administrative action?