How frequently must IRB continuing review occur for protocols that involve greater than minimal risk?

Protocols that involve greater than minimal risk are required to undergo continuing review by the Institutional Review Board (IRB) at least annually. This regulation helps ensure ongoing oversight of the research study, allowing the IRB to assess whether the risk to participants is still justified relative to the potential benefits.

The requirement for annual reviews is rooted in the need to protect participants throughout the duration of research activities, especially when higher risk is involved. By requiring this frequency, the IRB can check for potential developments that might affect participant safety, evaluate new information about the risks of the intervention, and ensure that the research procedures continue to remain ethical and compliant with regulatory standards.

In cases where the level of risk changes or significant new information becomes available, the IRB may require more frequent review or even an expedited review process. However, these situations do not replace the baseline requirement for annual review, which serves as a standardized time frame for all studies involving greater than minimal risk.