Continuing Review

Maintaining approval

IRBs are responsible for continuing review of ongoing research to ensure the rights and welfare of human subjects are protected.

Published ICMS guidance calls for review at intervals appropriate to risk and at least annually, evaluating the progress of the entire study, not only changes. Confirm the requirements applicable to your study with the reviewing IRB.

• Submit continuing review materials before approval expires.
• Provide the current informed consent document.
• Provide a written progress report from the clinical investigator.
• Include number of subjects entered, subject experiences, adverse reactions, withdrawals, reasons for withdrawals, study results to date, current risk-benefit assessment, and new information since the last review.
• Submit a final report when the study closes.
• Use the continuing review process for minor changes or updates to approved research.
• Failure to comply may result in suspension or expiration of IRB approval.

Non-compliance

Continuing research after IRB approval has expired is a regulatory violation. If the IRB has not reviewed and approved a study by the current expiration date, research activities should stop and no new subjects may be enrolled.