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 plans to enroll pregnant women in a study that offers the prospect of direct benefit only to the fetus. Under Subpart B (45 CFR 46), this is permissible only if:
Answer: The risk to the fetus is minimized and both the mother and father consent where feasible
Subpart B requires that when research holds direct benefit only for the fetus, risk to the fetus must be minimized and consent must be obtained from both the pregnant woman and the father where feasible.
Which of the following is an example of 'therapeutic misconception' in research?
Answer: A subject believes research participation is the same as receiving individualized medical treatment
Therapeutic misconception occurs when subjects fail to distinguish research participation from individualized medical care, attributing therapeutic intent to research procedures.
Under the revised Common Rule (2018), a single IRB (sIRB) review is REQUIRED for:
Answer: Cooperative research funded by a U.S. federal department or agency conducted at multiple domestic sites
The 2018 Common Rule mandates sIRB review for cooperative research conducted at multiple domestic institutions and funded by a federal department or agency covered by the rule.
When a subject withdraws consent from an ongoing study, the researcher must:
Answer: Cease collecting new data from the subject, but may retain previously collected data
Withdrawal of consent stops future data collection but does not require destruction of data already collected, which may be retained for analysis consistent with the consent form.
Which of the following best describes an 'unanticipated problem involving risks to subjects or others' (UPIRTSO)?
Answer: An unexpected occurrence that is related to the research and suggests increased risk
A UPIRTSO must be unexpected, related or possibly related to the research, and suggest that participants or others are at greater risk than previously recognized.
The Justice principle in the Belmont Report primarily addresses:
Answer: Fair distribution of research burdens and benefits across population groups
Justice requires equitable selection of subjects so that no group bears a disproportionate burden of research risks while others receive the benefits.
An IRB conducting continuing review must evaluate which of the following at minimum?
Answer: The number of subjects enrolled, any adverse events, and any new information affecting risk-benefit
At continuing review, the IRB must assess enrollment status, adverse events and protocol deviations, and any new findings that could alter the risk-benefit assessment.