Protocol Review & Approval Process Flashcards

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?

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.

When an IRB conducts continuing review, what must be evaluated to determine if the research may continue?

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.

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?

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).

Under federal regulations, what is the minimum quorum required for a convened IRB meeting to conduct business and approve research?

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.

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?

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.

What action must an IRB take when an investigator reports an unanticipated problem involving risks to subjects or others?

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.

Which of the following best describes the concept of 'equipoise' as it relates to IRB protocol review?

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.