Human Subjects Protection & Safety Flashcards
7 cards from real CIP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Human Subjects Protection & Safety flashcards as text
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?
Answer: Research on practices intended to improve the health and well-being of the prisoner population
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.
Which of the following scenarios constitutes a 'protocol deviation' rather than a 'protocol violation'?
Answer: A subject taking the study drug two hours later than scheduled with no impact on safety or data
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.
Under FDA regulations (21 CFR 50.25), which of the following is NOT a required basic element of informed consent?
Answer: The name of the IRB chair who reviewed the study
FDA regulations specify eight basic elements of informed consent; the identity of the IRB chair is not among them.
A pediatric study involves research with greater than minimal risk and no direct benefit to individual subjects. Under Subpart D, approval requires that:
Answer: The intervention presents only a minor increase over minimal risk and is likely to yield generalizable knowledge about the subject's disorder
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.
Which of the following best illustrates the concept of 'undue influence' in research recruitment?
Answer: An employer offering paid leave only to employees who enroll in a company-sponsored study
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.
When assessing the risk-benefit ratio of a research protocol, the IRB should:
Answer: Weigh anticipated benefits to individual subjects and to society against the probability and magnitude of harms
The IRB must balance potential benefits—both to subjects and to society through knowledge gained—against the probability and magnitude of all anticipated harms.
A Certificate of Confidentiality (CoC) issued by NIH protects researchers from being compelled to disclose:
Answer: Identifying information about research participants in legal proceedings
A Certificate of Confidentiality protects researchers from being forced to disclose identifying information about participants in any federal, state, or local civil, criminal, administrative, legislative, or other proceeding.