CIP Human Subjects Protection & Safety 4

Question 1

A researcher conducts a study exclusively with prisoners. Under Subpart C (45 CFR 46), which category of research may be approved without additional OHRP consultation?

Accepted Answer

Research on practices intended to improve the health and well-being of the prisoner population

Answer

Subpart C permits IRB approval without OHRP consultation for research on practices likely to improve health or well-being of the prisoner population, provided other conditions are met.

Question 2

Which of the following scenarios constitutes a 'protocol deviation' rather than a 'protocol violation'?

Accepted Answer

A subject taking the study drug two hours later than scheduled with no impact on safety or data

Answer

Minor deviations such as a slight timing difference that has no effect on safety or data integrity are protocol deviations; violations are deviations that affect subject safety or data validity.

Question 3

Under FDA regulations (21 CFR 50.25), which of the following is NOT a required basic element of informed consent?

Accepted Answer

The name of the IRB chair who reviewed the study

Answer

FDA regulations specify eight basic elements of informed consent; the identity of the IRB chair is not among them.

Question 4

A pediatric study involves research with greater than minimal risk and no direct benefit to individual subjects. Under Subpart D, approval requires that:

Accepted Answer

The intervention presents only a minor increase over minimal risk and is likely to yield generalizable knowledge about the subject's disorder

Answer

Under 45 CFR 46.406, research with greater than minimal risk and no direct benefit to subjects may be approved only if risk is a minor increase over minimal risk and the study is likely to yield vital knowledge about the subjects' disorder.

Question 5

Which of the following best illustrates the concept of 'undue influence' in research recruitment?

Accepted Answer

An employer offering paid leave only to employees who enroll in a company-sponsored study

Answer

Undue influence occurs when an excessive, unwarranted, or improper reward induces subjects to agree to research they would otherwise decline, such as employer-contingent benefits.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP Human Subjects Protection & Safety 4