How often must the IRB conduct continuing review of an approved protocol?

The requirement for the Institutional Review Board (IRB) to conduct continuing reviews of an approved protocol is mandated at least annually. This annual review ensures that the study continues to meet ethical standards and safeguards the welfare of the participants involved. During this review, the IRB assesses any changes to the research protocol, evaluates the ongoing risks to participants, and determines whether the benefits of the research continue to outweigh those risks.

This requirement aligns with federal regulations that emphasize the importance of continuous oversight of research involving human subjects. While some studies might necessitate more frequent reviews based on specific risks or circumstances, the baseline expectation is set at an annual review to provide a standard measure of oversight and protection for participants.

Elements like bi-annual reviews or every six months are often specific to certain types of studies or determined by the IRB’s discretion but are not the standard requirement for all studies. Additionally, the review cannot solely rely on the investigator's judgment about necessity; the IRB must adhere to established guidelines to ensure ongoing protection for research participants.