How often must IRB review protocols?

The requirement for IRB review of protocols is grounded in regulations aimed at protecting the rights and welfare of research participants. An Institutional Review Board (IRB) must review research protocols at least annually to ensure that the study continues to align with ethical standards and regulatory requirements. This review process is crucial for identifying any potential risks or changes in the research that may impact participant safety and welfare.

In addition to the annual review, if there are significant changes to the study protocol, such as modifications in methods, participant eligibility, or even changes in risk levels, the IRB must conduct a review of those changes before they can be implemented. This ongoing oversight underscores the importance of monitoring research studies throughout their duration, rather than limiting review to the initiation phase alone. The requirement for an annual review and additional assessments for significant changes ensures that the IRB maintains its commitment to protecting participants throughout the entire study lifecycle.