Review Process Flow Chart
The IRB review process begins when an investigator emails their Request for Review to the IRB Chair. The Chair screens the Request for Review to determine if the Request is complete and all required addenda and attachments are included. If the Request for Review is incomplete, it is returned to the investigator. If it is complete, the Chair determines the level of review based on the potential for risk to participants. Investigators submitting Requests for Review that the Chair determines are not human subjects studies receive a Determination Letter indicating as much and are ready to begin their project. If the Chair determines the Request for Review is exempt from continuing review, the investigator receives a Determination Letter stating that the research protocol has been approved and is exempt from continuing review. If the Chair determines the research potentially poses more than minimal but less than high risk to the participants, she assigns the Request to one or more IRB committee members for review. The reviewer(s) determine that the Request is either approved or requires modifications before it can be approved. The IRB Chair sends a Determination Letter with either an approval or notifying the investigator that modifications and resubmission are required. If the Chair decides the research protocol potentially poses high or moderately high risk to the participants the Request for Review is sent to all full IRB members for review and placed on the agenda for the following scheduled IRB meeting.
