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

No risk

Answer

Moderate risk

Answer

Greater than minimal risk

Question 2

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

Accepted Answer

A majority of IRB members

Answer

One-quarter of IRB members

Answer

One-third of IRB members

Answer

All IRB members

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

Research involving prisoners

Answer

Phase III drug trials

Answer

Research involving cognitive impairment

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

Only to FDA-regulated research

Answer

Only to privately funded research

Answer

When more than 100 subjects are enrolled

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

Risks to subjects are minimized

Answer

Equitable selection of subjects

Answer

Informed consent will be sought from each subject

Question 6

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

Accepted Answer

To represent community and non-scientific perspectives in the review

Answer

To ensure statistical validity of the protocol

Answer

To review financial disclosures

Answer

To serve as a tiebreaker in votes

Question 7

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

Accepted Answer

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

Answer

All human subjects research regardless of product involvement

Answer

Research funded by NIH grants only

Answer

Research conducted outside the United States only