What does the IRB/IEC determine as appropriate for continuing review?

• A. Scheduling the trial start date
• B. Determining the frequency of continuing review, as appropriate
• C. Deciding on the trial's budget
• D. Approving all amendments automatically

Answer: (C)

The main idea being tested is that the IRB/IEC determines how often a study must come back for continuing review. This frequency is set by the IRB based on the study’s level of risk, the safety data being generated, and any changes to the protocol or consent. For minimal-risk research, continuing reviews can be scheduled annually or even less often; for higher-risk studies or when new safety concerns arise, reviews may be required more frequently. The IRB’s role is to protect participants by re-evaluating the risk-benefit balance, consent updates, and overall conduct at those intervals. Decisions about the trial’s budget or start date aren’t within the IRB’s purview, and amendments aren’t approved automatically—they require IRB review and approval before they go into effect.