Review Categories
1. Exempt from IRB Review
Research activities involving human subjects in which there is minimal or no risk and in which the only involvement of human subjects would be in one of the categories described on the back of the form, “Request for Exempt Status,” may be considered by the IRB Office to be exempt from further IRB review. Projects that qualify for exempt status must, however, receive formal IRB certification of such exempt status. This certification serves as an assurance that the project 1) qualifies for exempt status in accordance with federal regulations, and 2) is designed to ensure that the rights and welfare of human subjects are protected. The “Request for Exempt State” form should be used to submit a project for exempt certification. IRB exempt status certification normally takes less than five days.
2. Expedited Review
Research activities involving no more than minimal risk and in which the only involvement of human subjects will be in one or more of the categories listed on the information sheet titled, “Expedited Review” will be scheduled for expedited review. In this procedure, three members of the IRB review the project and vote for approval, approval pending modifications, or disapproval. If two out of three reviewers vote disapproval, the project must go to the full board for review. The “Request for IRB Review” form should be used to submit a project for review in the expedited category. Expedited review normally takes less than two weeks.
3. Full Board Review
All projects involving human subjects that do not qualify for exempt or expedited review must be reviewed by the full IRB at an official meeting. After the IRB Chairperson determines that a “Request for IRB Review” requires this procedure, a full IRB meeting to review the request will be scheduled, normally within the following two weeks.