Which option correctly reflects the timing of continuing IRB oversight for non-exempt studies?

• A. IRB continuing review occurs at least annually; progress reports and adverse event reporting required; approvals renewed.
• B. IRB review is only at initial approval.
• C. IRB reviews every five years regardless of risk.
• D. IRB reviews only upon protocol changes.

Answer: (A)

Continuing IRB oversight for non-exempt studies is required to occur at least annually, with investigators submitting progress reports and adverse event information, and IRB approvals must be renewed to remain active. This ongoing review keeps protection of participants current as the study evolves—new risks, changes in procedures, recruitment status, or new information can alter the risk-benefit balance and the consent needs. Annual review ensures the study remains compliant with regulatory and ethical standards and that any problems are identified and addressed promptly.

If oversight happened only at initial approval, or only every five years regardless of risk, or only when protocol changes occur, important safety and ethical issues could go unchecked. Continual oversight with annual review and required reporting ensures participant safety and study integrity throughout the research.