CITI Institutional Review Board (IRB) Practice Test 2025 - Free IRB Practice Questions and Study Guide

Question: 1 / 400

Which scenario describes a situation that does not require reporting to the IRB?

A participant is injured during the study

A participant has an automobile accident after the study, unrelated to participation

In the context of research and the responsibilities of the Institutional Review Board (IRB), it is important to understand the parameters that necessitate reporting. The situation in which a participant experiences an automobile accident after the study, and that accident is unrelated to their participation in the study, does not require reporting to the IRB. This is because the IRB's primary concern is the ethical oversight of the research activities and the immediate well-being of the participants in relation to the study.

In this scenario, since the accident occurred after participation and is unrelated to the research activities, it falls outside the purview of the IRB. In contrast, cases involving injuries during the study, adverse effects reported during follow-ups, or breaches of confidentiality all involve direct implications that can impact participant safety or ethical standards within the research context. Such events are directly tied to the conduct of the study and could trigger necessary investigations and responses to protect participants and adhere to regulatory requirements. Thus, option B represents an instance where the IRB is not obligated to be notified, as it does not pertain to the conduct of the research.

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A participant reports adverse effects during a follow-up

Confidential data is leaked during the research

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