SOCRA Institutional Review Board (IRB) 2 — Questions and Answers
Question 1: Which level of risk is the maximum allowed for research to qualify for expedited IRB review?
- No risk
- Minimal risk (Correct answer)
- Moderate risk
- Greater than minimal risk
Correct answer: Minimal risk
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?
- One-quarter of IRB members
- One-third of IRB members
- A majority of IRB members (Correct answer)
- All IRB members
Correct answer: A majority of IRB members
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?
- Research involving prisoners
- Survey research with anonymous adult participants about non-sensitive topics (Correct answer)
- Phase III drug trials
- Research involving cognitive impairment
Correct 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.
Question 4: When does the Common Rule (45 CFR 46 Subpart A) apply to research?
- Only to FDA-regulated research
- When research is conducted or supported by a federal department or agency (Correct answer)
- Only to privately funded research
- When more than 100 subjects are enrolled
Correct 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.
Question 5: Which of the following is NOT a required element for full board IRB review approval?
- Risks to subjects are minimized
- Equitable selection of subjects
- The sponsor has approved the protocol (Correct answer)
- Informed consent will be sought from each subject
Correct answer: The sponsor has approved the protocol
Sponsor approval is not a regulatory criterion for IRB approval; IRBs evaluate ethical and safety criteria independently.
Question 6: What is the primary purpose of having a non-scientist member on an IRB?
- To ensure statistical validity of the protocol
- To represent community and non-scientific perspectives in the review (Correct answer)
- To review financial disclosures
- To serve as a tiebreaker in votes
Correct 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.
Question 7: Under 21 CFR Part 56, which type of research falls under FDA IRB regulations?
- All human subjects research regardless of product involvement
- Research involving FDA-regulated products such as drugs, biologics, and devices (Correct answer)
- Research funded by NIH grants only
- Research conducted outside the United States only
Correct 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.
SOCRA Institutional Review Board (IRB) 2
Which level of risk is the maximum allowed for research to qualify for expedited IRB review?