The PI will be notified if anything further is needed after a review. If changes are required, the report will detail them and indicate the IRB action as "approval pending." Once the recommended changes are made to the satisfaction of the primary reader, the review process is complete and IRB approval is given.
After approval: if you plan on making any changes to your approved study.
Investigators are responsible for reporting any proposed changes to the IRB, including changes to the human subjects research protocol, measures, or informed consent documents. This applies to changes in the research design, changes to procedures that could introduce new or increased risks to human subjects, and anything which may change the nature of the research. Any such changes, or "amendments," require IRB review and approval before they are introduced into the research. Please visit Mentor IRB, download and complete the amendment summary form. Instructions on how to submit your amendment for review can be found on the Info Page on Mentor IRB.
You will receive notice when your study approval is going to expire. If you will be continuing your study, you must apply for renewal. Instructions for completing and submitting your continuing application and documentation, can be found on the Info Page on Mentor IRB.