What is required for a continuing review of an ongoing study approved by an IRB?

For a continuing review of an ongoing study approved by an Institutional Review Board (IRB), it is required to occur within 12 months of the last IRB approval date. This periodic review is necessary to ensure the ongoing protection of participants and to assess whether the study continues to meet ethical standards and regulatory requirements. By reviewing the study annually or more frequently, the IRB can evaluate any changes in risks, consent processes, and overall study conduct to ensure the protection of human subjects.

The option specifying a 12-month timeframe aligns with federal regulations, which state that the IRB must conduct reviews at least annually for studies that are not exempt. This ensures that all ongoing studies maintain their ethical compliance and participant safety throughout the duration of the research.