SOCRA Institutional Review Board (IRB) 2

Question 1

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

Accepted Answer

Minimal risk

Answer

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

Question 2

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

Accepted Answer

A majority of IRB members

Answer

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

Question 3

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

Accepted Answer

Survey research with anonymous adult participants about non-sensitive topics

Answer

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

Question 4

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

Accepted Answer

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

Answer

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

Question 5

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

Accepted Answer

The sponsor has approved the protocol

Answer

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

(SOCRA) Society of Clinical Research Associates Practice Test