How often must a continuing review of an approved and ongoing protocol occur?

The requirement for a continuing review of an approved and ongoing research protocol is that it must occur at least within 12 months of the initial or most recent approval date. This mandate is set to ensure that all research involving human subjects maintains ethical standards, safety, and compliance with regulatory guidelines throughout the entire duration of the study. Conducting these reviews allows the Institutional Review Board (IRB) or other oversight bodies to assess any new risks, evaluate any adverse effects, and determine whether the protocol still meets ethical standards, thus ensuring the ongoing protection of participants.

In contrast, while some frequency options like every month or every 6 months might seem reasonable, they do not reflect the established timeframes outlined in regulations. The choice of every 18 months would also exceed the maximum allowable duration for a review, making it non-compliant with the standard practices. Compliance with the 12-month timeframe helps balance the need for oversight with the operational efficiency required by researchers conducting ongoing studies.