What is the time frame for a continuing review of an approved study posing more than minimal risk?

The requirement for a continuing review of an approved study that poses more than minimal risk is typically set to occur at least once a year. This annual review process is crucial to ensure the ongoing safety of the participants and to evaluate the study's risk-benefit ratio as it progresses. It allows institutional review boards (IRBs) to monitor the study for any emerging issues, adverse events, or changes in the risk profile that could affect the participants.

While there are other time frames associated with different levels of studies or types of reviews, the mandate for annual reviews for higher-risk studies underscores the importance of vigilance in research ethics and participant safety. This ensures that any potential risks are continuously assessed and that the study remains aligned with ethical standards and regulatory requirements.