CIP Protocol Review & Approval Process 2 — Questions and Answers
Question 1: Which IRB review category is appropriate for research involving collection of blood samples via venipuncture from healthy adults, where samples are collected in amounts not exceeding 550 ml in an 8-week period?
- Full board review
- Expedited review under Category 2 (Correct answer)
- Exempt review under Category 1
- No IRB review required
Correct answer: Expedited review under Category 2
Venipuncture from healthy adults within quantity and frequency limits qualifies for expedited review under 45 CFR 46.110 Category 2.
Question 2: When an IRB conducts continuing review, what must be evaluated to determine if the research may continue?
- Only adverse events reported since last approval
- The risk-benefit ratio, progress of research, and any new information affecting the risk assessment (Correct answer)
- Whether enrollment targets have been met
- The investigator's publication record related to the study
Correct answer: The risk-benefit ratio, progress of research, and any new information affecting the risk assessment
Continuing review requires the IRB to reassess the entire protocol including risk-benefit ratio, study progress, and new information that may affect subject safety.
Question 3: A protocol involves a survey on sensitive personal topics but participants are fully anonymous with no way to link responses to individuals. Which exempt category most likely applies?
- Category 1 — educational settings
- Category 2 — surveys/interviews without identifiers where disclosure cannot harm subjects (Correct answer)
- Category 4 — existing data
- Category 6 — taste and food quality evaluation
Correct answer: Category 2 — surveys/interviews without identifiers where disclosure cannot harm subjects
Anonymous surveys where disclosure of responses cannot reasonably place subjects at risk qualify for exemption under Category 2 of 45 CFR 46.101(b).
Question 4: Under federal regulations, what is the minimum quorum required for a convened IRB meeting to conduct business and approve research?
- A simple majority of all IRB members
- All voting members must be present
- At least one-third of voting members
- More than half of the IRB membership, including one non-scientist member (Correct answer)
Correct answer: More than half of the IRB membership, including one non-scientist member
45 CFR 46.108(b) requires a quorum of more than half the IRB membership, and that quorum must include a member whose primary concerns are nonscientific.
Question 5: An investigator submits a request for a minor modification to an already-approved protocol (e.g., correcting a typographical error in the consent form). Which review process is most appropriate?
- Full convened board review
- Expedited review by the IRB chair or designated reviewer (Correct answer)
- Exempt determination
- The modification requires no IRB action
Correct answer: Expedited review by the IRB chair or designated reviewer
Minor amendments that do not increase risk or substantially alter the research may be reviewed and approved through expedited review by a designated reviewer.
Question 6: What action must an IRB take when an investigator reports an unanticipated problem involving risks to subjects or others?
- Automatically suspend the study pending a full investigation
- Review the report and determine if any action is warranted, such as modification, suspension, or termination (Correct answer)
- Forward the report to the FDA without further IRB review
- Require the investigator to re-obtain consent from all enrolled subjects
Correct answer: Review the report and determine if any action is warranted, such as modification, suspension, or termination
Upon receiving an unanticipated problem report, the IRB must review it and decide on appropriate responsive actions, which could range from no change to suspension or termination.
Question 7: Which of the following best describes the concept of 'equipoise' as it relates to IRB protocol review?
- The balance between direct benefits and indirect benefits to participants
- Genuine uncertainty in the expert community about the relative merits of each treatment arm in a clinical trial (Correct answer)
- Equal distribution of risks across all participant subgroups
- The requirement that placebo and active treatment groups be of equal size
Correct answer: Genuine uncertainty in the expert community about the relative merits of each treatment arm in a clinical trial
Equipoise refers to genuine uncertainty among experts about which intervention is superior, which is a key ethical justification for randomized controlled trials.
CIP Protocol Review & Approval Process 2
Which IRB review category is appropriate for research involving collection of blood samples via venipuncture from healthy adults, where samples are collected in amounts not exceeding 550 ml in an 8-week period?