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
Under the Common Rule, which of the following activities is NOT considered 'research' requiring IRB oversight?
Answer: Quality improvement projects designed solely to improve local practice
Quality improvement projects intended solely to improve local practice, not to generate generalizable knowledge, do not meet the regulatory definition of research.
A researcher wants to conduct a secondary analysis of de-identified data from a hospital registry. Under 45 CFR 46, this would most likely be:
Answer: Exempt under Category 4 if the data cannot be re-identified
Research involving secondary analysis of existing de-identified data commonly qualifies for exemption under Category 4 of the revised Common Rule when re-identification is not possible.
The principle of 'respect for persons' in the Belmont Report requires that:
Answer: Individuals with diminished autonomy must be protected and autonomous agents must be treated as such
Respect for persons incorporates two convictions: individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection.
A DSMB (Data Safety Monitoring Board) is most critically needed in which type of study?
Answer: A phase III randomized controlled trial with a mortality endpoint
DSMBs are most essential in trials with serious endpoints such as mortality, where ongoing safety monitoring may require early stopping to protect participants.
Which of the following best describes a 'waiver of documentation of informed consent' under 45 CFR 46.117(c)?
Answer: Allowing consent without a signed form when the only link to identity is the signature itself
A waiver of documentation of consent is appropriate when the signature would be the only record linking the subject to the research, creating a greater breach risk than the research itself.
An IRB is reviewing a protocol involving deception. For approval, the IRB must determine that:
Answer: Deception is necessary, subjects will not be harmed, and debriefing will be provided
When deception is used, the IRB must confirm it is scientifically necessary, subjects will not be harmed, and a debriefing plan is in place to disclose the true purpose afterward.
According to 45 CFR 46, 'minimal risk' is defined as the probability and magnitude of harm not greater than:
Answer: The risks encountered in daily life or routine physical or psychological examinations
The regulatory definition of minimal risk benchmarks against harms ordinarily encountered in daily life or during routine physical or psychological examinations or tests.