CIP Protocol Review & Approval Process 2

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?

Accepted Answer

Expedited review under Category 2

Answer

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?

Accepted Answer

The risk-benefit ratio, progress of research, and any new information affecting the risk assessment

Answer

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?

Accepted Answer

Category 2 — surveys/interviews without identifiers where disclosure cannot harm subjects

Answer

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?

Accepted Answer

More than half of the IRB membership, including one non-scientist member

Answer

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?

Accepted Answer

Expedited review by the IRB chair or designated reviewer

Answer

Minor amendments that do not increase risk or substantially alter the research may be reviewed and approved through expedited review by a designated reviewer.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP Protocol Review & Approval Process 2