Continuing review of an approved study posing more than minimal risk must occur:

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The requirement for continuing review of an approved study that poses more than minimal risk is stipulated to ensure ongoing oversight and protection of participants involved in the research. Continuing review must occur within a defined timeframe to evaluate any changes in the study's risk profile, the progress of the research, and the informed consent process.

The correct timing for this review is within 12 months of the approval date. This annual review is essential for maintaining ethical standards and ensuring that the risks to participants are minimized and that the benefits of the research continue to outweigh those risks. Frequent review helps to monitor compliance with the original protocols and safeguard participant well-being throughout the duration of the study.

In contrast, conducting reviews every semester or every two years would not align with the requirements established by regulatory bodies, which specify annual reviews for studies with more than minimal risk. The option stating every year for five years does not accurately capture the ongoing requirement for annual reviews after initial approval; regulatory standards emphasize that these reviews should happen on an annual basis as long as the study is active, which exceeds the five-year timeframe suggested.

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