When must continuing review of an ongoing study posing more than minimal risk occur?

Continuing review of an ongoing study posing more than minimal risk must occur at least once within 12 months of the initial approval date, ensuring that the institutional review board (IRB) evaluates the study's progress, assesses any new risks, and verifies that the study continues to meet ethical standards. This requirement is in place to protect participants by ensuring that their rights and welfare are continuously monitored throughout the study.

While some studies may require more frequent reviews based on specific risk factors, the standard timeframe for continuing reviews is annually, which aligns with the framework established by federal regulations. This ensures that the oversight remains timely and relevant, allowing for adjustments to the study protocols based on evolving information or participant safety considerations.