PRC Institutional Review Board Processes 2

Question 1

A researcher wants to conduct a phone survey about dietary habits with no identifiers collected. Which IRB review category most likely applies?

Accepted Answer

Exempt review

Answer

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?

Accepted Answer

At intervals appropriate to the degree of risk, at least annually for non-exempt research

Answer

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?

Accepted Answer

They represent the community perspective and are unaffiliated with the institution

Answer

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?

Accepted Answer

Submit a protocol amendment to the IRB before implementing the change

Answer

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?

Accepted Answer

Prisoners

Answer

Prisoners are explicitly identified as a vulnerable population under Subpart C of 45 CFR 46, requiring additional safeguards.

(PRC) Professional Researcher Certification Practice Test