How often must the IRB review ongoing clinical trials?

The requirement for the Institutional Review Board (IRB) to review ongoing clinical trials is fundamentally based on the need to ensure the continued protection of the rights and welfare of human subjects participating in research. According to federal regulations, the IRB must conduct continuing review of research at least annually. This annual review process allows the IRB to assess the progress of the trial, any adverse events that may have occurred, changes in the research protocol, and ensure that the informed consent process remains appropriate.

An annual review is essential because it helps to ensure that any potential risks to participants are being minimized and that the study continues to meet ethical standards throughout its duration. The regulations also allow for more frequent reviews if necessary, depending on the nature of the research and any risks identified, but a minimum of once a year is the established standard. This practice promotes transparency and accountability in clinical research.