Continuing review of an approved study that poses more than minimal risk must occur within what timeframe?

For studies that pose more than minimal risk, continuing review must occur at least once every 12 months. This requirement is in place to ensure that the ethical standards and safety of participants are continuously monitored throughout the research process. The 12-month timeframe allows for sufficient oversight of the study's progress, any adverse events that may arise, changes to the study protocol, and the ongoing assessment of risk versus benefit to participants.

Following this practice helps to protect the welfare of the participants and ensure compliance with ethical guidelines. This regulation also aligns with federal regulations, which stipulate that studies involving greater than minimal risk must not go longer than one year without a review to assess the conditions under which the research is being conducted. By requiring this regular scrutiny, the integrity of the research and the safety of those involved are prioritized.

The alternatives, suggesting intervals of 6, 18, or 24 months, do not align with the established guidelines that govern research with higher risk levels and would pose a potential risk to participants’ safety by allowing longer intervals without necessary oversight.