Institutional Review Board (IRB) Flashcards

Which level of risk is the maximum allowed for research to qualify for expedited IRB review?

Answer: Minimal risk

Expedited review is permitted only for research that presents no more than minimal risk to subjects.

What constitutes a quorum for a convened IRB meeting under federal regulations?

Answer: A majority of IRB members

A quorum requires a majority of IRB members to be present, including at least one non-scientist member.

Which category of research is most likely to qualify as EXEMPT under 45 CFR 46?

Answer: Survey research with anonymous adult participants about non-sensitive topics

Anonymous survey research with adults on non-sensitive topics typically qualifies for exempt status under Category 2.

When does the Common Rule (45 CFR 46 Subpart A) apply to research?

Answer: When research is conducted or supported by a federal department or agency

The Common Rule applies to research that is conducted or supported by any federal department or agency that has adopted it.

Which of the following is NOT a required element for full board IRB review approval?

Answer: The sponsor has approved the protocol

Sponsor approval is not a regulatory criterion for IRB approval; IRBs evaluate ethical and safety criteria independently.

What is the primary purpose of having a non-scientist member on an IRB?

Answer: To represent community and non-scientific perspectives in the review

Non-scientist members bring community and lay perspectives that help the IRB evaluate ethical issues beyond scientific merit.

Under 21 CFR Part 56, which type of research falls under FDA IRB regulations?

Answer: Research involving FDA-regulated products such as drugs, biologics, and devices

FDA's IRB regulations (21 CFR Part 56) apply specifically to research involving FDA-regulated products including drugs, biologics, and medical devices.