CRS Institutional Review Board Procedures 2 — Questions and Answers
Question 1: Which federal regulation primarily governs IRB review of human subjects research at institutions receiving federal funding?
- 21 CFR Part 50
- 45 CFR Part 46 (Correct answer)
- 29 CFR Part 1910
- 40 CFR Part 26
Correct answer: 45 CFR Part 46
45 CFR Part 46, known as the Common Rule, is the primary federal regulation governing human subjects protections and IRB review.
Question 2: A researcher wants to conduct a minimal-risk survey of adults about their dietary habits. Which IRB review category is most appropriate?
- Full board review
- Expedited review
- Exempt review (Correct answer)
- No review required
Correct answer: Exempt review
Anonymous surveys on non-sensitive topics with minimal risk typically qualify for exempt review under 45 CFR 46.104(d)(2).
Question 3: What is the maximum period for which an IRB can grant approval before requiring continuing review under the pre-2018 Common Rule?
- 6 months
- 1 year (Correct answer)
- 2 years
- 3 years
Correct answer: 1 year
Under the pre-2018 Common Rule, IRB approval expires after one year unless the IRB grants a shorter approval period.
Question 4: Which of the following research activities is explicitly excluded from IRB review under the revised 2018 Common Rule?
- Secondary analysis of identifiable data
- Research involving prisoners
- Quality improvement projects at non-federal sites
- Scholarly and journalistic activities (Correct answer)
Correct answer: Scholarly and journalistic activities
The 2018 Common Rule explicitly excludes scholarly and journalistic activities, along with public health surveillance and certain other activities, from its scope.
Question 5: An IRB member has a financial interest in a company sponsoring a study under review. What must occur?
- The member may vote but not discuss the study
- The member must recuse themselves from the review (Correct answer)
- The member may participate if they disclose the conflict
- The member may observe but the chair decides their vote
Correct answer: The member must recuse themselves from the review
IRB members with conflicting interests must recuse themselves from the discussion and vote for that study.
Question 6: What does the term 'assurance' refer to in the context of IRB regulations?
- A researcher's promise to follow protocol
- An institution's agreement with OHRP to comply with human subjects regulations (Correct answer)
- IRB certification that a study is safe
- A participant's agreement to take part in research
Correct answer: An institution's agreement with OHRP to comply with human subjects regulations
An assurance (FWA - Federalwide Assurance) is an institution's formal agreement with OHRP to comply with 45 CFR Part 46.
Question 7: When must an IRB conduct full board review rather than expedited review?
- When the research involves adults only
- When the research involves greater than minimal risk (Correct answer)
- When the research involves a survey instrument
- When the PI has a conflict of interest
Correct answer: When the research involves greater than minimal risk
Full board review is required when research poses greater than minimal risk to participants.
CRS Institutional Review Board Procedures 2
Which federal regulation primarily governs IRB review of human subjects research at institutions receiving federal funding?