PRC Institutional Review Board Processes 2 — Questions and Answers
Question 1: A researcher wants to conduct a phone survey about dietary habits with no identifiers collected. Which IRB review category most likely applies?
- Full board review
- Expedited review
- Exempt review (Correct answer)
- Emergency use authorization
Correct answer: Exempt review
Anonymous surveys on non-sensitive topics typically qualify for exempt review under 45 CFR 46.104.
Question 2: When must an IRB conduct continuing review of an approved study?
- Only when a serious adverse event occurs
- At intervals appropriate to the degree of risk, at least annually for non-exempt research (Correct answer)
- Every five years regardless of risk
- Only when the PI requests it
Correct answer: At intervals appropriate to the degree of risk, at least annually for non-exempt research
Federal regulations require continuing review at intervals appropriate to risk, with annual review as a common minimum standard.
Question 3: Which of the following best describes the role of a community member on an IRB?
- They must hold a doctoral degree in social science
- They represent the community perspective and are unaffiliated with the institution (Correct answer)
- They are required to review all exempt protocols
- They serve primarily to meet quorum for expedited reviews
Correct answer: They represent the community perspective and are unaffiliated with the institution
Federal regulations require at least one non-scientist and one member unaffiliated with the institution to represent the community viewpoint.
Question 4: A PI realizes mid-study that a new data collection procedure could increase participant risk. What is the required next step?
- Continue the study and report at the next scheduled review
- Suspend the study and notify participants immediately
- Submit a protocol amendment to the IRB before implementing the change (Correct answer)
- Obtain verbal consent from participants and proceed
Correct answer: Submit a protocol amendment to the IRB before implementing the change
Any changes that may increase risk to participants must be reviewed and approved by the IRB before implementation.
Question 5: Under the Common Rule, which population is classified as a vulnerable group requiring additional protections?
- Graduate students over age 18
- Healthy adult volunteers
- Prisoners (Correct answer)
- Retired military personnel
Correct answer: Prisoners
Prisoners are explicitly identified as a vulnerable population under Subpart C of 45 CFR 46, requiring additional safeguards.
Question 6: What is a 'certificate of confidentiality' in the context of research ethics?
- A pledge signed by participants to keep study results private
- A legal protection preventing compelled disclosure of identifiable research data (Correct answer)
- A form researchers use to de-identify data before publication
- An IRB certification that a study poses no confidentiality risk
Correct answer: A legal protection preventing compelled disclosure of identifiable research data
A Certificate of Confidentiality is a federal protection that prevents researchers from being compelled to disclose identifiable research information in legal proceedings.
Question 7: Which factor does NOT typically influence whether a study qualifies for expedited rather than full board review?
- The level of risk to participants
- Whether the research involves only minimal risk
- The size of the researcher's budget (Correct answer)
- The procedures used for data collection
Correct answer: The size of the researcher's budget
Funding level is not a criterion for determining review category; risk level and procedure type are the primary factors.
PRC Institutional Review Board Processes 2
A researcher wants to conduct a phone survey about dietary habits with no identifiers collected.
Which IRB review category most likely applies?