IRB Post Approval
In its initial review, the IRB will determine the continuing review period. Federal Regulations (45 CFR 46) require review before or on the 12-month anniversary date of the previous IRB approval date. All research reviewed by expedited and Full Board Review is required to be reviewed at least annually. Exempt Research is not required to submit an annual review, however, changes to the study should be submitted to the IRB to make sure the study continues to meet exempt criteria.
The IRB must approve all modifications to the research activities before implemented. Submissions are submitted through Cayuse IRB. When the changes to the research do not meet the minimal risk definition, the changes will have to be reviewed at the Full Board. The changes will be assessed by the risks and benefits of the research or substantially changes the specific aims or design of the study.
Adverse Events and Deviations
Investigators are responsible to report any adverse events or deviations from the IRB approved study in Cayuse. Any change, divergence, or departure from the design or procedures that affects the participant’s rights, safety or welfare must be promptly reported to the IRB. Changes in the conduct of the trial which does not affect the safety or welfare of the participants’ rights, safety, or well-being, or on the completeness, accuracy, and reliability of the study data also represents non-compliance and should be reported. In example, the enrollment of more participants that the number initially approved for is non-compliance and will need to be reported.
Closing the Study
If all research activities involving human participants have been completed, the investigators are no longer required to obtain continuing review and approval for the study. Researches should inform the IRB of the completion of the study by submitting a closure report through Cayuse IRB.