How often must IRBs review ongoing research studies?

The requirement for Institutional Review Boards (IRBs) to review ongoing research studies is established to ensure the continued protection of human subjects. Annual reviews are mandated to assess whether the research is still ethically sound, whether risks to subjects have changed, and whether the rights and welfare of participants remain adequately protected.

IRBs consider various factors during these reviews, including the study's adherence to the original protocol, any adverse events, and changes in risk assessments or regulatory standards that might affect the study's ethical standing. By conducting these reviews at least annually, IRBs can address any issues that may arise and make necessary recommendations or require adjustments to the study to enhance participant safety.

While it is important for IRBs to remain vigilant and review studies more frequently if circumstances change significantly (such as in cases of serious adverse events), the minimum standard set by federal regulations is an annual review. This frequency allows for a balance between oversight and the practicalities of conducting research. Therefore, the choice indicating at least annually is the correct answer, as it aligns with regulatory requirements and best practices in human subjects protection.