In the described illicit drug use research scenario, the unanticipated problem must be reported to the IRB in which timeframe?

In the described illicit drug use research scenario, the unanticipated problem must be reported to the IRB in which timeframe?

• A. Promptly
• B. Within 24 hours
• C. Within 5 business days
• D. Immediately

Answer: (A)

Unanticipated problems involving risk to subjects or others must be reported to the IRB promptly. This means you notify the IRB as soon as you become aware of the issue, without unnecessary delay, even if you don’t yet have all the details. The important point is timely action so the IRB can review the situation, protect participants, and determine any required corrective steps. While institutions may have specific follow-up timelines, the guiding requirement is to report promptly rather than waiting for a fixed number of hours or days. After the initial report, you’ll provide updates as more information becomes available.

Unanticipated problems involving risk to subjects or others must be reported to the IRB promptly. This means you notify the IRB as soon as you become aware of the issue, without unnecessary delay, even if you don’t yet have all the details. The important point is timely action so the IRB can review the situation, protect participants, and determine any required corrective steps. While institutions may have specific follow-up timelines, the guiding requirement is to report promptly rather than waiting for a fixed number of hours or days. After the initial report, you’ll provide updates as more information becomes available.