IRB Post Approval
During initial review, the IRB will determine an appropriate period for continuing review, based on federal regulations and evaluation of project-specific information. Continuing review periods may be annual (for projects subject to the Revised Common Rule (45 CFR 46) that receive Full Board Review, projects subject to FDA oversight that involve investigation of new drugs and/or devices), every five years (for projects subject to the Revised Common Rule that receive Expedited review), or a custom period at the discretion of the IRB. Continuing review of protocols that are determined to be exempt from IRB oversight is not required, but changes to the study should be discussed with an IRB Administrator to make sure the study continues to meet exempt criteria.
The IRB must approve all modifications to the research activities before implemented. Modifications are submitted through Cayuse IRB. As a general practice, modifications are reviewed at the same level of oversight as the original submission, unless the modifications require an increased level of oversight. In such a case, the IRB will determine the appropriate increased level of review.
Adverse Events and Deviations
Investigators are responsible for reporting any adverse events associated with their research or deviations from the approved IRB protocol. Any change, divergence, or departure from the design or procedures (intended or not) that affects the participant’s rights, safety or welfare must be reported to the IRB promptly. Changes in the conduct of research which do not affect the safety or welfare of the participants’ rights, safety, or well-being, or compromise the completeness, accuracy, and reliability of the study data also represent non-compliance need to be reported. These events can be reported to an IRB Administrator who will help the PI submit a report in Cayuse IRB.
Closing the Study
Once all research activities involving human participants or their identifiable data or biospecimens have been completed, continuing review is no longer required. In this event, the researchers should inform the IRB Administrator of completion of the study and submitting a Closure Request through Cayuse IRB.