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

The requirement for continuing review of an ongoing study that poses more than minimal risk is to ensure that the study remains ethical and that the risk to participants is still justified by the potential benefits. The correct answer indicates that this review must occur within 12 months of the initial approval date. This timeframe is established by regulatory guidelines to protect participant welfare and to ensure compliance with oversight bodies. By mandating a review within this specific period, institutions can assess any new information related to the risks involved, monitor adverse events, and determine whether the study should continue as originally approved or require modifications.

The other options do not accurately reflect the regulatory requirements. While some studies may be reviewed every 6 months or annually, the key factor for studies posing more than minimal risk is the necessity of review within 12 months, ensuring oversight is consistent with ethical standards. The option suggesting that review occurs only upon the request of the investigator undermines the structured oversight necessary for maintaining participant safety and the integrity of the research.